SURGICAL LIFT SHEET— 510(k) K942807

Substantially Equivalent

Surgin Surgical Instrumentation, Inc.

FDA 510(k) clearance K942807 for SURGICAL LIFT SHEET, Substantially Equivalent on 1994-08-02. Applicant: Surgin Surgical Instrumentation, Inc..

Clearance details

Applicant: Surgin Surgical Instrumentation, Inc.
Product code: Code FSA
Advisory panel: General Hospital
Date received: 1994-06-14
Decision date: 1994-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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Adverse events under product code FSA

product code FSA

Death: 101
Injury: 767
Malfunction: 1,173
Other: 1
Total: 2,042

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.