510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232943Substantially Equivalent

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

Abbott Medical, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232943 is the FDA 510(k) clearance record for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe, a class II device, cleared for Smiths Medical Asd, Inc. on under FDA product code QNQ (Low Dead Space Piston Syringe). FDA's definition for product code QNQ reads: "A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for...". FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K232943.

Clearance record

Decision date
Received
(254 days to decision)
Product code
QNQ Low Dead Space Piston Syringe
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Smiths Medical Asd, Inc. 6000 Nathan Ln. N, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNQ

Trailing 12 months
1 clearance under product code QNQ in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QNQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260