510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041779Substantially Equivalent

Nipro Disposable Stopcocks, Models 3W-Rc. Ncn-3, 3W-R, 3W-L

Nipro Medical Corporation, Lexington KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041779 is the FDA 510(k) clearance record for NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L, a class II device, cleared for Nipro Medical Corp. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 62 510(k) clearances for Nipro Medical Corp., from to . As of , FDA records show no recalls naming K041779.

Clearance record

Decision date
Received
(82 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Nipro Medical Corp. 1384 Copperfield Ct., Lexington KY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

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