PENTAX EPK-I5020 VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Upper GI Scopes (EG Family)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pentax Medical Video Duodenoscope ED32-i10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Video Colonoscopes (EC Family)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Auto Leakage Tester SHA-P6

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Gas/Water Feeding Valve OE-B14

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Bronchoscope EB11-J10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EKP-i5010 Video Processor with EB Family

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Endoscopic Ultrasound System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-i7010 Video Processor with GI Family

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical ENT Video Imaging System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pentax Medical Video Duodenoscope ED34-i10T2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology