CONCEPT SUCTION SLEEVE— 510(k) K850423

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K850423 for CONCEPT SUCTION SLEEVE, Substantially Equivalent on 1985-03-14. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code HTZ
Advisory panel: General, Plastic Surgery
Date received: 1985-02-04
Decision date: 1985-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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Adverse events under product code HTZ

product code HTZ

Malfunction: 1,133
Total: 1,133

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.