Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K232329Substantially Equivalent

Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter

Medivators (A Subsidiary of Steris Corporation), Conroe TX / Traditional, Substantially Equivalent

K232329 is the FDA 510(k) clearance record for Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter, a class II device, cleared for Medivators (A Subsidiary of Steris Corporation) on under FDA product code ODC (Endoscope Channel Accessory). FDA's definition for product code ODC reads: "To give the endoscope channel additional or improved functionality". FDA records list 3 510(k) clearances for Medivators (A Subsidiary of Steris Corporation), from to . As of , FDA records show no recalls naming K232329.

Clearance record

Decision date
Received
(140 days to decision)
Product code
ODC Endoscope Channel Accessory
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medivators (A Subsidiary of Steris Corporation) 3150 Pollok Dr., Conroe TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODC

Trailing 12 months
1 clearance under product code ODC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ODC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260