INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
FDA 510(k) clearance K091215 · decided 2009-05-18
Clearance details
- K-number
- K091215
- Device name
- INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-27
- Decision date
- 2009-05-18
- Days to decision
- 21 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 Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply recall (Z-0409-2010) | Surgical Devices/Covidien | 2009-11-23 |