PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233942

Identifiers

510(k) Number: K233942 FDA 510(k)
FDA Product Code: FDT FDA 510(k)
Models / Variants: PENTAX Medical Video Duodenoscope (ED34-i10T2s) FDA 510(k)EUDAMED
PENTAX Medical Video Processor (EPK-i8020c) FDA 510(k)EUDAMED
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63) FDA 510(k)EUDAMED
Gas/Water Feeding Valves (OF-B194 ) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The PENTAX Medical Video Duodenoscope (ED34-i10T2s) System is a flexible endoscopic device designed for diagnostic and therapeutic procedures in the duodenum, bile ducts, and pancreatic ducts. It includes a video duodenoscope, a video processor, a single-use sterile distal end cap with elevator, and gas/water feeding valves, enabling high-resolution imaging and precise manipulation during procedures such as Endoscopic Retrograde Cholangiopancreatography (ERCP).

This system is intended for use in clinical settings such as gastroenterology and urology, where infection control is critical. The duodenoscope (ED34-i10T2s) and video processor (EPK-i8020c) are reusable and require proper reprocessing, while the single-use sterile distal end cap (OE-A63) and gas/water feeding valves (OF-B194) are designed for single-use to minimize contamination risks. The device is classified under FDA 510(k) and MDR regulations, with a clearance type of Traditional and a decision code of SESE. The system is compatible with Sterrad sterilization and includes components with specific registration numbers for traceability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video ..., Video Duodenoscope [ED34-i10T2s], ED34-i10T2 Duodenoscope: Advanced infection control - PENTAX Medical, Video Duodenoscope [ED34-i10T]

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K233942	Class II	Active

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Manufacturer

Manufacturer: PENTAX of America, Inc.

Sources (2)

FDA 510(k) K233942 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026