STERILE LAPAROTOMY SPONGES— 510(k) K934971

Name: FDA 510(k) clearance K934971
Creator: U.S. Food and Drug Administration
Published: 1994-02-07

Substantially Equivalent

Medsurg Industries, Inc.

FDA 510(k) clearance K934971 for STERILE LAPAROTOMY SPONGES, Substantially Equivalent on 1994-02-07. Applicant: Medsurg Industries, Inc.. Device class: 1.

Clearance details

Applicant: Medsurg Industries, Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1993-10-18
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, 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.