SPONGE COUNTER— 510(k) K926225

Name: FDA 510(k) clearance K926225
Creator: U.S. Food and Drug Administration
Published: 1993-03-05

Substantially Equivalent

American Medical Manufacturer, Inc.

FDA 510(k) clearance K926225 for SPONGE COUNTER, Substantially Equivalent on 1993-03-05. Applicant: American Medical Manufacturer, Inc.. Device class: 1.

Clearance details

Applicant: American Medical Manufacturer, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1992-12-10
Decision date: 1993-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canoga Park, CA, US

Download summary PDF View on FDA.gov ↗

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K944779 — CARBON LIGHTS HAND SURGERY TABLE1994-10-14
K935381 — KAPS POSITIONING ARM1994-04-15
K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)1993-07-30

Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.