510(k) K163216
K163216 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Pinpoint GT Needles". The FDA issued a decision of Substantially Equivalent on Jun 27, 2017. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 2017
- Date Received
- Nov 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type
- 510(k)