CONDOM-52.XX— 510(k) K812250

Substantially Equivalent

Manfred Sauer Corp.

FDA 510(k) clearance K812250 for CONDOM-52.XX, Substantially Equivalent on 1981-08-20. Applicant: Manfred Sauer Corp..

Clearance details

Applicant: Manfred Sauer Corp.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1981-08-11
Decision date: 1981-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.