SURGICAL LOOPS— 510(k) K812389

Substantially Equivalent

Berkeley Medevices

FDA 510(k) clearance K812389 for SURGICAL LOOPS, Substantially Equivalent on 1981-11-16. Applicant: Berkeley Medevices.

Clearance details

Applicant: Berkeley Medevices
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1981-08-20
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.