FMS DUO
FDA 510(k) clearance K954465 · decided 1995-11-09
Clearance details
- K-number
- K954465
- Device name
- FMS DUO
- Applicant
- Future Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-25
- Decision date
- 1995-11-09
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- New York City, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide recall (Z-0658-2016) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2016-01-15 |
| DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The I recall (Z-0192-2014) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-11-08 |