CONMED VCARE RETRACTOR/ELEVATOR
FDA 510(k) clearance K955446 · decided 1996-06-18
Clearance details
- K-number
- K955446
- Device name
- CONMED VCARE RETRACTOR/ELEVATOR
- Applicant
- Conmedcorp
- Decision
- Substantially Equivalent
- Date received
- 1995-11-29
- Decision date
- 1996-06-18
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Dayton, OH, 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) STANDARD, Uterine Manipulator, REF recall (Z-0178-2009) | ConMed Corporation | 2008-10-28 |
| VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60 recall (Z-0179-2009) | ConMed Corporation | 2008-10-28 |
| VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60 recall (Z-0180-2009) | ConMed Corporation | 2008-10-28 |