510(k) K023051
K023051 is an FDA 510(k) premarket notification submitted by Prosurg, Inc. for the device "INTRAUTERINE DELIVERY SYSTEM - INJECTOR". The FDA issued a decision of Substantially Equivalent on Dec 12, 2002. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Prosurg, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2002
- Date Received
- Sep 13, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Manipulator/Injector, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type