Medical Device Manufacturer · KR , Daegu

Finemedix Co., Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2018

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Finemedix Co., Ltd. Gastroenterology & Urology ✕

10 devices

1-10 of 10

Cleared Aug 21, 2025

ClearTip FNA and FNB Types

K250994 · FCG

Gastroenterology & Urology · 142d

Cleared May 21, 2025

ClearHemograsper

K242857 · KGE

Gastroenterology & Urology · 243d

Cleared Aug 20, 2024

ClearCap Distal Attachment

K242134 · OCX

Gastroenterology & Urology · 29d

Cleared Jun 30, 2023

ClearTip

K231267 · FCG

Gastroenterology & Urology · 59d

Cleared Feb 19, 2021

ClearCap Distal Attachment

K202616 · OCX

Gastroenterology & Urology · 163d

Cleared Oct 05, 2020

ClearEndoclip

K200217 · PKL

Gastroenterology & Urology · 251d

Cleared Jun 28, 2019

ClearEndoclip

K183021 · PKL

Gastroenterology & Urology · 239d

Cleared Mar 06, 2019

ClearGrasp Snare

K183289 · FDI

Gastroenterology & Urology · 100d

Cleared Dec 21, 2018

Clear-Jet Injection Catheter

K181690 · FBK

Gastroenterology & Urology · 178d

Cleared Nov 01, 2018

Clear-Tip EUS-FNA

K180363 · FCG

Gastroenterology & Urology · 265d

Regulatory Intelligence

Regulatory consultants 510(k) submission support ecosystem

LK Consulting Group USA, Inc.

Withus Group, Inc.

KMC, Inc.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026

Finemedix Co., Ltd. - FDA 510(k) Cleared Devices

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