Clear-Tip EUS-FNA— 510(k) K180363

Clearance details

Applicant

Finemedix Co., Ltd.

Product code

Code FCG

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2018-02-09

Decision date

2018-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Daegu, KR

• K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)2025-10-24
• K250994 — ClearTip FNA and FNB Types2025-08-21
• K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)2024-07-29
• K231422 — Precision GI2023-08-28
• K231267 — ClearTip2023-06-30

• K251478 — ClearTip TBNA Type2026-04-16
• K242857 — ClearHemograsper2025-05-21
• K242134 — ClearCap Distal Attachment2024-08-20
• K202616 — ClearCap Distal Attachment2021-02-19
• K200217 — ClearEndoclip2020-10-05

Death

13

Injury

576

Malfunction

1,966

Total

2,555

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →