510(k) K163437
K163437 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "hypodermic Pinpoint GT Needle". The FDA issued a decision of Substantially Equivalent on June 23, 2017. The device falls under product code PVZ (Non-Stainless Steel Needle), a Class II device regulated under 21 CFR 880.5570. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2017
- Date Received
- December 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Stainless Steel Needle
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use.