SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG— 510(k) K854737

Substantially Equivalent

Orthopaedic Devices , Ltd.

FDA 510(k) clearance K854737 for SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG, Substantially Equivalent on 1986-05-19. Applicant: Orthopaedic Devices , Ltd..

Clearance details

Applicant: Orthopaedic Devices , Ltd.
Product code: Code FQH
Advisory panel: General Hospital
Date received: 1985-11-26
Decision date: 1986-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woods Cross, UT, US

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.