STERILE GAUZE SPONGES X-RAY DETECTABLE— 510(k) K922054

Name: FDA 510(k) clearance K922054
Creator: U.S. Food and Drug Administration
Published: 1992-08-10

Substantially Equivalent

Team Mfg., Inc.

FDA 510(k) clearance K922054 for STERILE GAUZE SPONGES X-RAY DETECTABLE, Substantially Equivalent on 1992-08-10. Applicant: Team Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Team Mfg., Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1992-05-04
Decision date: 1992-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

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K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE1996-02-22
K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03

More clearances from Team Mfg., Inc.

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K922055 — STERILE AND NON-STERILE GAUZE SPONGES1992-08-10
K904934 — AUTOMASTER1991-05-21

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.