VCARE RETRACTOR/ELEVATOR
FDA 510(k) clearance K071907 · decided 2007-10-05
Clearance details
- K-number
- K071907
- Device name
- VCARE RETRACTOR/ELEVATOR
- Applicant
- Conmed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-07-10
- Decision date
- 2007-10-05
- Days to decision
- 87 days
- Clearance type
- Special
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Utica, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged o recall (Z-1520-2011) | ConMed Corporation | 2011-03-03 |
| VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF recall (Z-0175-2009) | ConMed Corporation | 2008-10-28 |
| VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60 recall (Z-0176-2009) | ConMed Corporation | 2008-10-28 |
| VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60 recall (Z-0177-2009) | ConMed Corporation | 2008-10-28 |
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| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |