MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS— 510(k) K113028
Substantially EquivalentMedisiss
FDA 510(k) clearance K113028 for MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS, Substantially Equivalent on 2011-12-20. Applicant: Medisiss. Device class: 2.
Clearance details
- Applicant
- Medisiss
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
Recent devices under product code HRX
view allMore clearances from Medisiss
view all- K100543 — MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
- K081559 — GENESIS
- K042659 — MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
- K030598 — MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
- K030919 — SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . 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.