SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS— 510(k) K850634

Substantially Equivalent

Surgidyne, Inc.

FDA 510(k) clearance K850634 for SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS, Substantially Equivalent on 1985-06-28. Applicant: Surgidyne, Inc..

Clearance details

Applicant: Surgidyne, Inc.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1985-02-19
Decision date: 1985-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.