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Medical DevicesKOSDAQ 38757064 approvals

Finemedix Co., Ltd.

Official website

KOSDAQ-listed medical device company producing ESD/EMR endoscopic devices such as ClearCut Knife and Clear-Jet Injector.

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Business overview

Source: DART corporate disclosure

Founded in 2009 and listed on KOSDAQ in 2024, Finemedix is a medical device company specializing in gastrointestinal endoscopic instruments. It produces ESD/EMR devices including ClearCut Knife, Clear-Jet Injector, and ClearGrasp Snare, ERCP devices FineTome and FineGrab Basket, and the HD-550 flexible endoscope system. ClearCut Knife holds over 20% domestic market share, the company supplies Japan via an ODM contract with Gadelius, and its products hold MFDS, European CE, and US FDA 510(K) approvals along with ISO 13485 and KGMP quality certifications.

Products & technology

  • ClearCut KnifeESD (Endoscopic Submucosal Dissection)
  • Clear-Jet InjectorESD and EMR (Endoscopic Mucosal Resection)
  • ClearGrasp SnareEMR and polypectomy
  • ClearTip FNA/FNBEUS FNA and FNB
  • FineTomeERCP procedure device
  • FineGrab BasketERCP gallstone retrieval basket
  • Clear EndoClipEndoscopic hemostasis and closure
  • Clear HemostatEndoscopic cauterization hemostasis
  • HD-550Flexible gastrointestinal endoscope system

Regulatory approvals

data.go.kr · openFDA

53 Korean MFDS device approvals · 2010–2026 / 11 US FDA 510(k) · 2018–2026

  • MFDSLight source, endoscope2026-07-30
    Product approval · Class 2수인 26-4508 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2026-07-21
    Product approval · Class 2제인 26-4667 호
  • MFDSSystem, medical image processing device2026-06-17
    Product approval · Class 1수신 26-1329 호
  • FDAClearTip TBNA Type2026-04-16
    510(k) · TraditionalEar, Nose, ThroatK251478
  • MFDSDuodenoscope, video2026-04-06
    Product approval · Class 2수인 26-4235 호
  • MFDSIrrigation unit, general purpose, electrically-powered2026-03-24
    Product approval · Class 2수인 26-4197 호
  • MFDSAnalyser, gastric acid2026-02-05
    Product approval · Class 1수신 26-299 호
  • MFDSPneumoperitoneum apparatus2026-01-14
    Product approval · Class 2수인 26-4052 호
  • MFDSScraper, cytology, single-use2025-12-24
    Product approval · Class 2제인 25-5197 호
  • MFDSScraper, cytology, single-use2025-11-27
    Product approval · Class 2제인 25-5110 호
  • MFDSUltrasonic endoscope2025-10-01
    Product approval · Class 2수인 25-4578 호
  • MFDSUltrasonic endoscope2025-10-01
    Product approval · Class 2수인 25-4576 호
Show 52 more
  • FDAClearTip FNA and FNB Types2025-08-21
    510(k) · TraditionalGastroenterology, UrologyK250994
  • MFDSCatheter guidewire, enteral2025-07-28
    Product approval · Class 2제인 25-4669 호
  • FDAClearHemograsper2025-05-21
    510(k) · TraditionalGastroenterology, UrologyK242857
  • MFDSLight source, endoscope2025-05-08
    Product approval · Class 2수인 25-4271 호
  • MFDSGastroscope, video2025-05-08
    Product approval · Class 2수인 25-4270 호
  • MFDSColonoscope, video2025-05-08
    Product approval · Class 2수인 25-4268 호
  • MFDSUltrasound imaging system, general-purpose2024-11-28
    Product approval · Class 2수인 24-643 호
  • MFDSSystem, medical image processing device2024-10-02
    Product approval · Class 1수신 24-1855 호
  • FDAClearCap Distal Attachment2024-08-20
    510(k) · SpecialGastroenterology, UrologyK242134
  • MFDSSpeculums2023-08-11
    Product approval · Class 1수신 23-1976 호
  • FDAClearTip2023-06-30
    510(k) · TraditionalGastroenterology, UrologyK231267
  • MFDSElectrosurgical system electrode, foot-controlled, single-useRevoked2022-03-15
    Product approval · Class 2제인 22-4201 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-useRevoked2021-08-17
    Product approval · Class 2제인 21-4708 호
  • MFDSScraper, cytology, single-use2021-05-20
    Product approval · Class 2제인 21-4423 호
  • MFDSScraper, cytology, single-use2021-05-06
    Product approval · Class 2수인 21-4207 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2021-05-04
    Product approval · Class 2수인 21-4206 호
  • MFDSEndotherapy needle, general-purpose, single-use2021-05-04
    Product approval · Class 2수인 21-4203 호
  • FDAClearCap Distal Attachment2021-02-19
    510(k) · TraditionalGastroenterology, UrologyK202616
  • FDAClearEndoclip2020-10-05
    510(k) · TraditionalGastroenterology, UrologyK200217
  • MFDSCholangiopancreatography catheter, single-use2020-09-17
    Product approval · Class 2제인 20-4862 호
  • MFDSClip, implantable, haemostatic2020-09-09
    Product approval · Class 2제인 20-4841 호
  • MFDSCholangiopancreatography catheter, single-useRevoked2020-08-14
    Product approval · Class 2제인 20-4755 호
  • MFDSCathter, bileduct, balloon2020-05-15
    Product approval · Class 2제인 20-4386 호
  • FDAClearEndoclip2019-06-28
    510(k) · TraditionalGastroenterology, UrologyK183021
  • MFDSSurgical clip applier, haemostatic, reusable2019-03-29
    Product approval · Class 1제신 19-406 호
  • FDAClearGrasp Snare2019-03-06
    510(k) · TraditionalGastroenterology, UrologyK183289
  • FDAClear-Jet Injection Catheter2018-12-21
    510(k) · TraditionalGastroenterology, UrologyK181690
  • FDAClear-Tip EUS-FNA2018-11-01
    510(k) · TraditionalGastroenterology, UrologyK180363
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2018-08-30
    Product approval · Class 2제인 18-4693 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2018-08-03
    Product approval · Class 2제인 18-4628 호
  • MFDSClip, implantable, haemostatic2018-07-23
    Product approval · Class 2제인 18-4578 호
  • MFDSBiopsy needle, general-purpose, single-useRevoked2018-05-17
    Product approval · Class 2제인 18-4377 호
  • MFDSAdaptor, endoscope element2017-12-18
    Product approval · Class 1제신 17-1421 호
  • MFDSScraper, cytology, single-useRevoked2017-11-20
    Product approval · Class 2수인 17-4713 호
  • MFDSScraper, cytology, single-use2017-07-06
    Product approval · Class 2제인 17-4544 호
  • MFDSElectrosurgical system electrode, foot-controlled, reusable2016-08-29
    Product approval · Class 2제인 16-647 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2015-06-25
    Product approval · Class 2제인 15-1016 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2015-06-11
    Product approval · Class 2제인 15-929 호
  • MFDSClinical ruler2015-05-22
    Product approval · Class 1대구 제신 15-40 호
  • MFDSEndoscopic lithotomy, resectoscope, single-use2015-04-09
    Product approval · Class 2제인 15-513 호
  • MFDSEndoscopic forceps, biopsy, electrically-powered, flexible2014-11-27
    Product approval · Class 2제인 14-2572 호
  • MFDSEndotherapy forceps, single-use2014-09-17
    Product approval · Class 2제인 14-1673 호
  • MFDSAdaptor, endoscope elementRevoked2013-06-11
    Product approval · Class 1대구 수신 13-41 호
  • MFDSAdaptor, endoscope element2012-11-28
    Product approval · Class 1대구 제신 12-74 호
  • MFDSEndotherapy needle, general-purpose, reusableRevoked2012-11-15
    Product approval · Class 1대구 제신 12-72 호
  • MFDSScraper, cytology, reusable2012-11-15
    Product approval · Class 1대구 제신 12-71 호
  • MFDSScraper, cytology, single-use2012-10-10
    Product approval · Class 2제인 12-1287 호
  • MFDSEndotherapy needle, general-purpose, single-use2011-12-05
    Product approval · Class 2제인 11-1321 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2010-09-13
    Product approval · Class 2제인 10-926 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2010-08-20
    Product approval · Class 2제인 10-847 호
  • MFDSSpeculumsRevoked2010-08-12
    Product approval · Class 1대구 제신 10-27 호
  • MFDSSpeculums2010-02-04
    Product approval · Class 1대구 제신 10-7 호
Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

MITECH CO.,LTD.17 shared

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

LivsMed Inc.6 shared

KOSDAQ-listed minimally invasive surgical device company developing the ArtiSential multi-jointed laparoscopic instrument and ArtiSeal vessel sealer.

SEJONG MEDICAL Co.Ltd.,4 shared

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

CLASSYS Inc.3 shared

CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.

SEWOONMEDICAL CO,. LTD.3 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

WSI Co., Ltd.3 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

Alpha AI Co.,Ltd.2 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

BTB Korea Co.,Ltd2 shared

KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.

Hironic Co.,Ltd2 shared

KOSDAQ-listed medical device company producing HIFU devices DOUBLO/V-RO and the Synerjet non-invasive drug delivery system for aesthetic dermatology.

meerecompanyIncorporated2 shared

Display and semiconductor equipment maker behind the panel-shaping Profiler tool and the Revo-i laparoscopic surgical robot.

SHINHUNG CO.,LTD2 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

WON TECH CO.,Ltd.2 shared

Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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