K935235

Substantially Equivalent

ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY

Applicant: Smith & Nephew Richards, Inc.
Product code: GCM
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-01
Decision date: 1995-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Adverse events under product code GCM

product code GCM

Malfunction: 1,233
Total: 1,233

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.