PSI SURGICAL ASPIRATOR— 510(k) K832100

Substantially Equivalent

Advanced Biosearch Assn.

FDA 510(k) clearance K832100 for PSI SURGICAL ASPIRATOR, Substantially Equivalent on 1983-10-04. Applicant: Advanced Biosearch Assn..

Clearance details

Applicant: Advanced Biosearch Assn.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1983-06-29
Decision date: 1983-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.