X-RAY DETECTABLE LAP SPONGES— 510(k) K812651

Name: FDA 510(k) clearance K812651
Creator: U.S. Food and Drug Administration
Published: 1981-10-20

Substantially Equivalent

Procter & Gamble Mfg. Co.

FDA 510(k) clearance K812651 for X-RAY DETECTABLE LAP SPONGES, Substantially Equivalent on 1981-10-20. Applicant: Procter & Gamble Mfg. Co.. Device class: 1.

Clearance details

Applicant: Procter & Gamble Mfg. Co.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1981-09-17
Decision date: 1981-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K861863 — MODIFIED PROTECTIVE GARMENT1986-08-11
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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.