PS-ROUND SURG. DRAIN & CONNECTOR— 510(k) K813377

Name: FDA 510(k) clearance K813377
Creator: U.S. Food and Drug Administration
Published: 1982-01-05

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K813377 for PS-ROUND SURG. DRAIN & CONNECTOR, Substantially Equivalent on 1982-01-05. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 1.

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1981-12-01
Decision date: 1982-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.