SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
FDA 510(k) clearance K021701 · decided 2002-06-21
Clearance details
- K-number
- K021701
- Device name
- SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-23
- Decision date
- 2002-06-21
- Days to decision
- 29 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 |
|---|---|---|
| Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Li recall (Z-0394-2010) | Surgical Devices/Covidien | 2009-11-23 |