IRRIGATION SET— 510(k) K822560

Substantially Equivalent

Utah Medical Products, Inc.

FDA 510(k) clearance K822560 for IRRIGATION SET, Substantially Equivalent on 1982-12-03. Applicant: Utah Medical Products, Inc..

Clearance details

Applicant: Utah Medical Products, Inc.
Product code: Code NBH
Advisory panel: Orthopedic
Date received: 1982-08-24
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBH

product code NBH

Injury: 516
Malfunction: 2,389
Total: 2,905

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.