ARTHROJET XT
FDA 510(k) clearance K041233 · decided 2004-07-28
Clearance details
- K-number
- K041233
- Device name
- ARTHROJET XT
- Applicant
- Hydrocision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-10
- Decision date
- 2004-07-28
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hopkonton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.