510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844343Substantially Equivalent

Top Single Use U.t.w. a-V Fistula Needle Y Type

Top Surgical Manufacturers Co., Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844343 is the FDA 510(k) clearance record for TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE, a class II device, cleared for Top Surgical Manufacturers Co. on under FDA product code FIE (Needle, Fistula). FDA records list 12 510(k) clearances for Top Surgical Manufacturers Co., from to . As of , FDA records show no recalls naming K844343.

Clearance record

Decision date
Received
(60 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Top Surgical Manufacturers Co. 7660 W. Fremont Ave., Littleton CO
Third party review
No

Clearances, product code FIE

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