SPONGE, LAPAROTOMY, VARIOUS SIZE— 510(k) K940436

Name: FDA 510(k) clearance K940436
Creator: U.S. Food and Drug Administration
Published: 1994-07-26

Substantially Equivalent

Shawnee Products, Inc.

FDA 510(k) clearance K940436 for SPONGE, LAPAROTOMY, VARIOUS SIZE, Substantially Equivalent on 1994-07-26. Applicant: Shawnee Products, Inc.. Device class: 1.

Clearance details

Applicant: Shawnee Products, Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1994-01-31
Decision date: 1994-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tecumseh, OK, US

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K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03

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.