PROTEC X-RAY DETECTABLE GAUZE SPONGE— 510(k) K955322

Name: FDA 510(k) clearance K955322
Creator: U.S. Food and Drug Administration
Published: 1995-12-19

Substantially Equivalent

Derivados DE Gasa, S.A. DE C.V.

FDA 510(k) clearance K955322 for PROTEC X-RAY DETECTABLE GAUZE SPONGE, Substantially Equivalent on 1995-12-19. Applicant: Derivados DE Gasa, S.A. DE C.V.. Device class: 1.

Clearance details

Applicant: Derivados DE Gasa, S.A. DE C.V.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1995-11-20
Decision date: 1995-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harobor, FL, US

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K955321 — PROTEC GAUZE SPONGE1995-12-19

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.