MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS— 510(k) K113028

Substantially Equivalent

Medisiss

FDA 510(k) clearance K113028 for MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS, Substantially Equivalent on 2011-12-20. Applicant: Medisiss.

Clearance details

Applicant: Medisiss
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2011-10-11
Decision date: 2011-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.