SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
FDA 510(k) clearance K020719 · decided 2002-05-10
Clearance details
- K-number
- K020719
- Device name
- SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-05
- Decision date
- 2002-05-10
- Days to decision
- 66 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Line recall (Z-0396-2010) | Surgical Devices/Covidien | 2009-11-23 |