SYNEVAC VACUUM SOURCE UNIT— 510(k) K831085

Substantially Equivalent

Synemed, Inc.

FDA 510(k) clearance K831085 for SYNEVAC VACUUM SOURCE UNIT, Substantially Equivalent on 1983-06-08. Applicant: Synemed, Inc..

Clearance details

Applicant: Synemed, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1983-04-04
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.