SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
FDA 510(k) clearance K003277 · decided 2000-12-21
Clearance details
- K-number
- K003277
- Device name
- SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
- Applicant
- Powermed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-19
- Decision date
- 2000-12-21
- Days to decision
- 63 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Powermed
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code recall (Z-0392-2010) | Surgical Devices/Covidien | 2009-11-23 |
| SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29) recall (Z-1048-03) | Power Medical Interventions | 2003-07-24 |
| SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33). recall (Z-1049-03) | Power Medical Interventions | 2003-07-24 |