GAUZE SPONGE X-RAY DETECTABLE-— 510(k) K832172

Name: FDA 510(k) clearance K832172
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Sudreca Surgical Dressings, Inc.

FDA 510(k) clearance K832172 for GAUZE SPONGE X-RAY DETECTABLE-, Substantially Equivalent on 1983-08-12. Applicant: Sudreca Surgical Dressings, Inc.. Device class: 1.

Clearance details

Applicant: Sudreca Surgical Dressings, Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1983-07-06
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sudreca Surgical Dressings, Inc.

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K832173 — GAUZE SPONGE STERILE1983-08-12
K832174 — GAUZE SPONGE NON-STERILE1983-08-12
K831952 — SURGICAL APPAREL SHOE COVERS1983-07-12

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.