510(k) K131491
K131491 is an FDA 510(k) premarket notification submitted by Kitazato Medical Co., Ltd. for the device "KITAZATO IUI CATHETER". The FDA issued a decision of Substantially Equivalent on September 11, 2013. 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
- September 11, 2013
- Date Received
- May 23, 2013
- 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