SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
FDA 510(k) clearance K040024 · decided 2004-02-04
Clearance details
- K-number
- K040024
- Device name
- SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-07
- Decision date
- 2004-02-04
- Days to decision
- 28 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
- New Hope, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stap recall (Z-0401-2010) | Surgical Devices/Covidien | 2009-11-23 |