URESIL 150CC BELLOWS RESERVOIR— 510(k) K863562

Substantially Equivalent

Uresil Corp.

FDA 510(k) clearance K863562 for URESIL 150CC BELLOWS RESERVOIR, Substantially Equivalent on 1986-09-29. Applicant: Uresil Corp..

Clearance details

Applicant: Uresil Corp.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1986-09-12
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, 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.