GYNECOLOGICAL CYSTO/URETHROSCOPE— 510(k) K800913

Substantially Equivalent

Kli

FDA 510(k) clearance K800913 for GYNECOLOGICAL CYSTO/URETHROSCOPE, Substantially Equivalent on 1980-05-14. Applicant: Kli.

Clearance details

Applicant: Kli
Product code: Code FGC
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-21
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FGC

product code FGC

Malfunction: 1,686
Total: 1,686

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.