510(k) K153606— LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application

Substantially Equivalent

Smith & Nephew

Clearance details

Applicant: Smith & Nephew
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2015-12-17
Decision date: 2016-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.