510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841409Substantially Equivalent

Bush Neck W/plug

Warne Surgical Products, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841409 is the FDA 510(k) clearance record for BUSH NECK W/PLUG, a class II device, cleared for Warne Surgical Products, Ltd. on under FDA product code BYZ (Trap, Sterile Specimen). FDA records list 15 510(k) clearances for Warne Surgical Products, Ltd., from to . As of , FDA records show no recalls naming K841409.

Clearance record

Decision date
Received
(13 days to decision)
Product code
BYZ Trap, Sterile Specimen
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Warne Surgical Products, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYZ

Trailing 12 months

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

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