Sphincterotome / short-wire compatible, Sterile Sphincterotome— 510(k) K210934

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K210934 for Sphincterotome / short-wire compatible, Sterile Sphincterotome, Substantially Equivalent on 2021-12-01. Applicant: Micro-Tech (Nanjing) Co., Ltd..

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-29
Decision date: 2021-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.