GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)— 510(k) K951911

Name: FDA 510(k) clearance K951911
Creator: U.S. Food and Drug Administration
Published: 1995-06-21

Substantially Equivalent

Commercial Resources New Mexico, Ltd.

FDA 510(k) clearance K951911 for GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE), Substantially Equivalent on 1995-06-21. Applicant: Commercial Resources New Mexico, Ltd.. Device class: 1.

Clearance details

Applicant: Commercial Resources New Mexico, Ltd.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1995-04-24
Decision date: 1995-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Cruces, NM, US

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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.