ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY— 510(k) K935235

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K935235 for ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY, Substantially Equivalent on 1995-03-23. Applicant: Smith & Nephew Richards, Inc..

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: 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

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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.