510(k) K023930
K023930 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "COOPERSURGICAL OOCYTE RECOVERY NEEDLES". The FDA issued a decision of Substantially Equivalent on January 22, 2003. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2003
- Date Received
- November 25, 2002
- 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