510(k) K112396
K112396 is an FDA 510(k) premarket notification submitted by Kitazato Medical Co., Ltd. for the device "IUI CATHETERS". The FDA issued a decision of Substantially Equivalent on November 2, 2012. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Kitazato Medical Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2012
- Date Received
- August 19, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type