COLOR VIDEO CAMERA— 510(k) K911485

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K911485 for COLOR VIDEO CAMERA, Substantially Equivalent on 1991-08-14. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-04
Decision date: 1991-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.