POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
FDA 510(k) clearance K052415 · decided 2005-09-29
Clearance details
- K-number
- K052415
- Device name
- POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-02
- Decision date
- 2005-09-29
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable recall (Z-1099-2007) | Power Medical Interventions, Inc | 2007-07-24 |