510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860449Substantially Equivalent

Modification Top Ultra Thinwall a-V Fistula Needle

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

K860449 is the FDA 510(k) clearance record for MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE, a class II device, cleared for Top Corp. on under FDA product code FIE (Needle, Fistula). FDA records list one 510(k) clearance for Top Corp. As of , FDA records show no recalls naming K860449.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Top Corp. 7660 W. Freemont 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