JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
FDA 510(k) clearance K103726 · decided 2012-02-08
Clearance details
- K-number
- K103726
- Device name
- JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-12-22
- Decision date
- 2012-02-08
- Days to decision
- 413 days
- Clearance type
- Traditional
- Product code
- KNF
- Device class
- 2
- Regulation number
- 884.4160
- 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 |
|---|---|---|
| Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart En recall (Z-2028-2012) | Integra Limited | 2012-07-18 |