HYDRASORB JOYCE SPONGE— 510(k) K925841

Name: FDA 510(k) clearance K925841
Creator: U.S. Food and Drug Administration
Published: 1993-05-12

Substantially Equivalent

Avitar, Inc.

FDA 510(k) clearance K925841 for HYDRASORB JOYCE SPONGE, Substantially Equivalent on 1993-05-12. Applicant: Avitar, Inc.. Device class: 1.

Clearance details

Applicant: Avitar, Inc.
Product code: Code NAC
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1992-11-18
Decision date: 1993-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NAC

product code NAC

Malfunction: 475
Total: 475

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.