Single Use Injection Needle— 510(k) K210917

Clearance details

Applicant

Anrei Medical (Hangzhou) Co., Ltd.

Product code

Code FBK

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2021-03-29

Decision date

2021-05-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou, CN

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• K202987 — Rescue Pulmonary Grasping Forceps2021-04-29
• K210660 — Stone Retrieval Balloon Catheter2021-04-27
• K201771 — Single Use Rotatable and Repositionable Hemoclip2020-10-19
• K192048 — Single Use Endoscope Valves Set2020-05-14

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 →