X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
FDA 510(k) clearance K041824 · decided 2005-01-07
Clearance details
- K-number
- K041824
- Device name
- X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
- Applicant
- Future Medical Systems, SA
- Decision
- Substantially Equivalent
- Date received
- 2004-07-06
- Decision date
- 2005-01-07
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- St. Jeannet, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provid recall (Z-0656-2016) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2016-01-15 |
| FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide recall (Z-0657-2016) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2016-01-15 |