GILL'S IRRIGATOR/ASPIRATOR NEEDLE— 510(k) K843925

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K843925 for GILL'S IRRIGATOR/ASPIRATOR NEEDLE, Substantially Equivalent on 1984-11-05. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1984-10-05
Decision date: 1984-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.