SNAP STERNUM SAW— 510(k) K935517

Substantially Equivalent

Surgiquip, Inc.

FDA 510(k) clearance K935517 for SNAP STERNUM SAW, Substantially Equivalent on 1994-03-10. Applicant: Surgiquip, Inc..

Clearance details

Applicant: Surgiquip, Inc.
Product code: Code HAB
Advisory panel: General, Plastic Surgery
Date received: 1993-11-18
Decision date: 1994-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code HAB

product code HAB

Injury: 283
Malfunction: 5,362
Total: 5,645

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.