Single-use Video Pancreaticobiliary Scope, PB Digital Controller— 510(k) K221784

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K221784 for Single-use Video Pancreaticobiliary Scope, PB Digital Controller, Substantially Equivalent on 2023-02-16. Applicant: Micro-Tech (Nanjing) Co., Ltd..

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2022-06-21
Decision date: 2023-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.