FLOSIMPLE ARTHROSCOPY PUMP A120
FDA 510(k) clearance K062380 · decided 2006-12-14
Clearance details
- K-number
- K062380
- Device name
- FLOSIMPLE ARTHROSCOPY PUMP A120
- Applicant
- W.O.M. World of Medicine AG
- Decision
- Substantially Equivalent
- Date received
- 2006-08-15
- Decision date
- 2006-12-14
- Days to decision
- 121 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the pat recall (Z-2243-2024) | WOM World Of Medicine AG | 2024-07-01 |