ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
FDA 510(k) clearance K024291 · decided 2003-03-20
Clearance details
- K-number
- K024291
- Device name
- ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
- Applicant
- Arthrex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-24
- Decision date
- 2003-03-20
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.