510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841119Substantially Equivalent

Tops Dispos. Infusion Set/hemodialysis

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

K841119 is the FDA 510(k) clearance record for TOPS DISPOS. INFUSION SET/HEMODIALYSIS, a class II device, cleared for Top Surgical Manufacturers Co. on under FDA product code KNZ (Accessories, A-V Shunt). FDA records list 12 510(k) clearances for Top Surgical Manufacturers Co., from to . As of , FDA records show no recalls naming K841119.

Clearance record

Decision date
Received
(36 days to decision)
Product code
KNZ Accessories, A-V Shunt
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Top Surgical Manufacturers Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KNZ

Trailing 12 months

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

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