FULL SPECTRUM ULE FIBER, MODEL FF101— 510(k) K920596

Name: FDA 510(k) clearance K920596
Creator: U.S. Food and Drug Administration
Published: 1994-09-06

Substantially Equivalent

Gerald J. Shirk, M.D.

FDA 510(k) clearance K920596 for FULL SPECTRUM ULE FIBER, MODEL FF101, Substantially Equivalent on 1994-09-06. Applicant: Gerald J. Shirk, M.D.. Device class: 2.

Clearance details

Applicant: Gerald J. Shirk, M.D.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1992-02-11
Decision date: 1994-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Rapids, IA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.