hypodermic Pinpoint GT Needle
FDA 510(k) K163437 · C.R. Bard, Inc.
510(k) numberK163437
Submission
- Device name
- hypodermic Pinpoint GT Needle
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- December 7, 2016
- Decision date
- June 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PVZ – Non-Stainless Steel Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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.
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Questions and answers
When was hypodermic Pinpoint GT Needle cleared by the FDA?
hypodermic Pinpoint GT Needle (K163437) received a 510(k) decision of Substantially Equivalent on June 23, 2017, 198 days after the submission was received.
What is the product code of K163437?
The FDA product code is PVZ – Non-Stainless Steel Needle, a Class II (moderate risk) device regulated under 21 CFR 880.5570.