ORC TAPPERED IRRIGATING PROBE— 510(k) K925024

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K925024 for ORC TAPPERED IRRIGATING PROBE, Substantially Equivalent on 1993-05-21. Applicant: O.R. Concepts, Inc..

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: 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

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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.