SILICONE IMPLANTS— 510(k) K812691

Substantially Equivalent

Sutter Biomedical, Inc.

FDA 510(k) clearance K812691 for SILICONE IMPLANTS, Substantially Equivalent on 1981-11-16. Applicant: Sutter Biomedical, Inc..

Clearance details

Applicant: Sutter Biomedical, Inc.
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1981-09-22
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.