510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163437Substantially Equivalent

hypodermic Pinpoint™ GT Needle

C.R. Bard Inc, Salt Lake Ciy, UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163437 is the FDA 510(k) clearance record for hypodermic Pinpoint™ GT Needle, a class II device, cleared for C.R. Bard, Inc. on under FDA product code PVZ (Non-Stainless Steel Needle). FDA's definition for product code PVZ 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". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K163437.

Clearance record

Decision date
Received
(198 days to decision)
Product code
PVZ Non-Stainless Steel Needle
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
C.R. Bard, Inc. 605 N. 5600 W., Salt Lake Ciy, UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PVZ

Trailing 12 months

FDA records hold no clearances under product code PVZ in the trailing twelve months.

FDA records show no clearances under product code PVZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PVZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260