Product code PVZ— General Hospital

hypodermic Pinpoint GT Needle

Classification name: Non-Stainless Steel Needle
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Total cleared: 1
First cleared: 2017-06-23
Most recent: 2017-06-23

FDA classification definition

“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.”
— U.S. Food and Drug Administration, device classification record for product code PVZ under 21 CFR 880.5570, via openFDA

Market context for product code PVZ

FDA has cleared 1 device under product code PVZ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PVZ

C.R. Bard, Inc.1 clearance

Recent clearances under product code PVZ

K163437 — hypodermic Pinpoint GT NeedleC.R. Bard, Inc.·2017-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.