510(k) K112462
K112462 is an FDA 510(k) premarket notification submitted by Kitazato Medical Co., Ltd. for the device "KITAZATO OPU NEEDLE". The FDA issued a decision of Substantially Equivalent on November 26, 2012. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Kitazato Medical Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 2012
- Date Received
- August 26, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6100
- Review Panel
- OB
- Submission Type