JARIT HULKA UTERINE TENACULUM FORCEPS
FDA 510(k) clearance K082349 · decided 2008-11-21
Clearance details
- K-number
- K082349
- Device name
- JARIT HULKA UTERINE TENACULUM FORCEPS
- Applicant
- J. Jamner Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-15
- Decision date
- 2008-11-21
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- HDC
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guide recall (Z-1305-2014) | Medtronic Vascular, Inc. | 2014-03-27 |