510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850111Substantially Equivalent

Aires Tuohy Needles 17Ga. X 4 1/2

Aries Medical, Inc., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850111 is the FDA 510(k) clearance record for AIRES TUOHY NEEDLES 17GA. X 4 1/2, a class II device, cleared for Aries Medical, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 19 510(k) clearances for Aries Medical, Inc., from to . As of , FDA records show no recalls naming K850111.

Clearance record

Decision date
Received
(10 days to decision)
Product code
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Applicant
Aries Medical, Inc. Two Gill St., Woburn MA
Third party review
No

Clearances, product code BSP

Trailing 12 months

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

FDA records show no clearances under product code BSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSP, 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