Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector

FDA 510(k) K232004 · Medivators (A Subsidiary of Steris Corporation)

Substantially Equivalent

510(k) numberK232004

Submission

Device name
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
Applicant
Medivators (A Subsidiary of Steris Corporation)
Conroe, TX, US
Received
July 6, 2023
Decision date
March 6, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ODC – Endoscope Channel Accessory
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To give the endoscope channel additional or improved functionality.

Other 510(k)s with product code ODC

510(k)DeviceApplicantDecision
K252933Dyne PortODC · Traditional Dyne Medical Group, Inc.06/12/2026SE
K250145Biopsy Port AdapterODC · Traditional Endosound, Inc.10/17/2025SE
K252910Orca Air/Water and Suction ValvesODC · Special Boston Scientific10/09/2025SESK
K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODC · Traditional Olympus Medical Systems Corporation07/16/2025SE
K250732Disposable Endoscopy Valve SetODC · Traditional Yangzhou Fartley Medical Instrument Technology…06/20/2025SE
K241842Luer-Split MAJ-2092ODC · Traditional Olympus Medical Systems Corporation03/19/2025SE
K250140Defendo Fujifilm 700 Single Use Cleaning AdapterODC · Special Steris Corparation02/20/2025SE
K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…ODC · Special STERIS Corporation11/08/2024SE
K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special STERIS Corporation10/11/2024SE
K241285Disposable Endoscope Valves Set (AF series)ODC · Traditional Alton (Shanghai) Medical Instruments Co., Ltd.10/01/2024SE

More from Alton (Shanghai) Medical Instruments Co., Ltd.

510(k)DeviceDecision
K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…ODC · Traditional 03/22/2024SE
K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…ODC · Traditional 12/21/2023SE

Questions and answers

When was Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector cleared by the FDA?

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector (K232004) received a 510(k) decision of Substantially Equivalent on March 6, 2024, 244 days after the submission was received.

What is the product code of K232004?

The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.