SURGICAL INSTRUMENT TRAY— 510(k) K944025

Substantially Equivalent

Riley Medical, Inc.

FDA 510(k) clearance K944025 for SURGICAL INSTRUMENT TRAY, Substantially Equivalent on 1994-11-22. Applicant: Riley Medical, Inc..

Clearance details

Applicant: Riley Medical, Inc.
Product code: Code FSM
Advisory panel: General, Plastic Surgery
Date received: 1994-08-17
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.