INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
FDA 510(k) clearance K083527 · decided 2008-12-18
Clearance details
- K-number
- K083527
- Device name
- INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-28
- Decision date
- 2008-12-18
- Days to decision
- 20 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
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm St recall (Z-0407-2010) | Surgical Devices/Covidien | 2009-11-23 |