IUI CATHETERS
FDA 510(k) clearance K112396 · decided 2012-11-02
Clearance details
- K-number
- K112396
- Device name
- IUI CATHETERS
- Applicant
- Kitazato Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-19
- Decision date
- 2012-11-02
- Days to decision
- 441 days
- Clearance type
- Traditional
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.