SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
FDA 510(k) clearance K032701 · decided 2003-09-30
Clearance details
- K-number
- K032701
- Device name
- SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-02
- Decision date
- 2003-09-30
- 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 |
|---|---|---|
| Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Dig recall (Z-0393-2010) | Surgical Devices/Covidien | 2009-11-23 |
| SurgAssist System Circular Stapler DLU 29mm recall (Z-0252-04) | Power Medical Interventions | 2003-12-19 |
| SurgAssist System Circular Stapler DLU 33mm recall (Z-0253-04) | Power Medical Interventions | 2003-12-19 |