Clear-Jet Injection Catheter— 510(k) K181690

Clearance details

Applicant

Finemedix Co., Ltd.

Product code

Code FBK

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2018-06-26

Decision date

2018-12-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Daegu, KR

• K260262 — Injection Needle2026-05-29
• K253598 — InjecSURE Injection System2026-03-31
• K252021 — Disposable Endoscopic Injection Needles2025-12-02
• K252247 — Injector Force Max Single Use Injector (4 models)2025-10-16
• K241595 — EzVu Visual Vasopressor injector (EV-19)2025-02-27

• K251478 — ClearTip TBNA Type2026-04-16
• K250994 — ClearTip FNA and FNB Types2025-08-21
• K242857 — ClearHemograsper2025-05-21
• K242134 — ClearCap Distal Attachment2024-08-20
• K231267 — ClearTip2023-06-30

Other

1

Total

1

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 →