Disposable Distal Cap— 510(k) K253139

Substantially Equivalent

Mirco-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K253139 for Disposable Distal Cap, Substantially Equivalent on 2026-03-19. Applicant: Mirco-Tech (Nanjing) Co., Ltd..

Clearance details

Applicant: Mirco-Tech (Nanjing) Co., Ltd.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-25
Decision date: 2026-03-19
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.