ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST.— 510(k) K810393

Substantially Equivalent

Keymed, Inc.

FDA 510(k) clearance K810393 for ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST., Substantially Equivalent on 1981-03-02. Applicant: Keymed, Inc..

Clearance details

Applicant: Keymed, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1981-02-17
Decision date: 1981-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.