VARIOUS DISPOSABLE KITS/TRAYS/INSTRU— 510(k) K840976

Substantially Equivalent

Carapace, Inc.

FDA 510(k) clearance K840976 for VARIOUS DISPOSABLE KITS/TRAYS/INSTRU, Substantially Equivalent on 1984-05-31. Applicant: Carapace, Inc..

Clearance details

Applicant: Carapace, Inc.
Product code: Code FSM
Advisory panel: General, Plastic Surgery
Date received: 1984-03-06
Decision date: 1984-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.