Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible— 510(k) K211021

Clearance details

Applicant

Micro-Tech (Nanjing) Co., Ltd.

Product code

Code FGE

Device class

Class 2

Regulation

21 CFR 876.5010

Advisory panel

Gastroenterology, Urology

Date received

2021-04-05

Decision date

2022-05-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Narijing, CN

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• K243388 — Disposable Distal Cap2025-06-27
• K243471 — Extraction Basket2024-12-16

Death

52

Injury

2,347

Malfunction

9,798

Other

1

Total

12,198

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 →