K925024

Substantially Equivalent

ORC TAPPERED IRRIGATING PROBE

Applicant: O.R. Concepts, Inc.
Product code: GCY
Advisory panel: General, Plastic Surgery
Date received: 1992-10-02
Decision date: 1993-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, TX, US

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.