TOMAC STERILE DISP. LAP SPONGE— 510(k) K812554

Name: FDA 510(k) clearance K812554
Creator: U.S. Food and Drug Administration
Published: 1981-09-24

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K812554 for TOMAC STERILE DISP. LAP SPONGE, Substantially Equivalent on 1981-09-24. Applicant: American Convertors Div., American Pharmaseal. Device class: 1.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1981-09-08
Decision date: 1981-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.