510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012157Substantially Equivalent

Churchill Medical Systems Stopcock

Vygon Mfg, Dover NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012157 is the FDA 510(k) clearance record for CHURCHILL MEDICAL SYSTEMS STOPCOCK, a class II device, cleared for Churchill Medical Systems, Inc. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 12 510(k) clearances for Vygon MFG, from to . As of , FDA records show one recall naming K012157.

Clearance record

Decision date
Received
(62 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Churchill Medical Systems, Inc. 87 Venture Dr., Dover NH
510(k) summary
Summary
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