P-S SUCTION RESERVOIR— 510(k) K801443

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K801443 for P-S SUCTION RESERVOIR, Substantially Equivalent on 1980-07-14. Applicant: Pudenz-Schulte Medical Research Corp..

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1980-06-20
Decision date: 1980-07-14
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.