SURGICAL ASPIRATOR— 510(k) K850946

Substantially Equivalent for Some Indications

Medicalex

FDA 510(k) clearance K850946 for SURGICAL ASPIRATOR, Substantially Equivalent for Some Indications on 1985-09-16. Applicant: Medicalex.

Clearance details

Applicant: Medicalex
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1985-03-07
Decision date: 1985-09-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Paris 75013, FR

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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.