SNAP STERNUM SAW— 510(k) K935517

Name: FDA 510(k) clearance K935517
Creator: U.S. Food and Drug Administration
Published: 1994-03-10

Substantially Equivalent

Surgiquip, Inc.

FDA 510(k) clearance K935517 for SNAP STERNUM SAW, Substantially Equivalent on 1994-03-10. Applicant: Surgiquip, Inc.. Device class: 1.

Clearance details

Applicant: Surgiquip, Inc.
Product code: Code HAB
Device class: Class 1
Regulation: 21 CFR 878.4820
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

Download summary PDF View on FDA.gov ↗

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More clearances from Surgiquip, Inc.

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K935322 — SNAP BONE REAMER1994-01-28
K935357 — SNAP RECIPROCATING SAW1994-01-28
K931769 — SNAP OSCILLATING SAW1994-01-27
K935516 — SNAP DRILL1994-01-27

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.