IDRIVES, IDRIVEC, IDRIVEF
FDA 510(k) clearance K073001 · decided 2007-12-18
Clearance details
- K-number
- K073001
- Device name
- IDRIVES, IDRIVEC, IDRIVEF
- Applicant
- Power Medical Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-24
- Decision date
- 2007-12-18
- Days to decision
- 55 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 Delivery System, Straight, product code iDriveS; Intelligent Delivery System, recall (Z-0406-2010) | Surgical Devices/Covidien | 2009-11-23 |