510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PVZClass II

Non-Stainless Steel Needle

21 CFR 880.5570 / General Hospital
FDA source (opens on fda.gov)

PVZ is the FDA product code for Non-Stainless Steel Needle, a class II device type, regulated under 21 CFR 880.5570. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
PVZ
Device name
Non-Stainless Steel Needle
FDA 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.
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
1

Clearances, product code PVZ

By decision year
1 clearance under product code PVZ with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PVZ by decision year
YearClearances
20171

Applicants with the most clearances

Product code PVZ
Applicants holding the most 510(k) clearances under product code PVZ
ApplicantClearances
C.R. Bard Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code