Medical Device Manufacturer · KR , Daegu

Finemedix Co., Ltd.

10 submissions · 10 cleared · Since 2018
10
Total
10
Cleared
0
Denied

Finemedix Co., Ltd. — FDA 510(k) Submissions

Finemedix Co., Ltd. has submitted 10 FDA 510(k) premarket notifications since 2018, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Biopsy Needle, Hemostatic Metal Clip For The Gi Tract, Endoscopic Irrigation/suction System, Endoscopic Injection Needle, Gastroenterology-urology, Snare, Flexible . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
ClearTip FNA and FNB Types
K250994 · FCG Biopsy Needle · Gastroenterology & Urology
Aug 2025 142d
ClearHemograsper
K242857 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
May 2025 243d
ClearCap Distal Attachment
K242134 · OCX Endoscopic... · Gastroenterology & Urology
Aug 2024 29d
ClearTip
K231267 · FCG Biopsy Needle · Gastroenterology & Urology
Jun 2023 59d
ClearCap Distal Attachment
K202616 · OCX Endoscopic... · Gastroenterology & Urology
Feb 2021 163d
ClearEndoclip
K200217 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Oct 2020 251d
ClearEndoclip
K183021 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jun 2019 239d
ClearGrasp Snare
K183289 · FDI Snare, Flexible · Gastroenterology & Urology
Mar 2019 100d
Clear-Jet Injection Catheter
K181690 · FBK Endoscopic Injection... · Gastroenterology & Urology
Dec 2018 178d
Clear-Tip EUS-FNA
K180363 · FCG Biopsy Needle · Gastroenterology & Urology
Nov 2018 265d
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