Pentax of America, Inc.
FDA 510(k) medical device clearances.
Top product codes for Pentax of America, Inc.
Recent clearances by Pentax of America, Inc.
- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K233942 — 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 )
- K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
- K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
- K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14
- K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
- K213235 — PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
- K223072 — PENTAX Medical Video Esophagoscope EE17-J10
- K220465 — PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
- K212814 — C2 CryoBalloon Ablation System
- K210928 — PENTAX Medical Video Bronchoscope EB11-J10
- K210177 — PENTAX Medical Video Upper GI Scopes EG17-J10
- K212201 — PENTAX Medical Auto Leakage Tester SHA-P6
- K210485 — PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
- K210710 — PENTAX Medical Video Duedenoscope ED34-i10T2
- K202365 — Pentax Medical Video Duodenoscope ED32-i10
- K203166 — PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- K203024 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- K200678 — PENTAX Medical Video Bronchoscope EB-J10 Series
- K200090 — PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
- K190805 — 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
- K192245 — Pentax Medical Video Duodenoscope ED34-i10T2
- K190799 — PENTAX Medical Video Upper GI Scopes (EG Family)
- K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
- K183516 — PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- K183691 — PENTAX Medical ENT Video Imaging System
- K183654 — PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
- K181084 — PENTAX Video Colonoscopes (EC Family)
- K182846 — PENTAX Medical EPK-3000 Video Imaging System
- K182004 — PENTAX Medical Endoscopic Ultrasound System
- K181522 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
- K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
- K173554 — PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
- K162151 — PENTAX Medical ENT Video Imaging System
- K162447 — 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
- K150618 — PENTAX Medical EPK-i7010 Video Processor with GI Family
- K143727 — PENTAX Medical EKP-i5010 Video Processor with EB Family
- K130206 — PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
- K130247 — PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
- K113873 — PENTAX EPK-I5020 VIDEO PROCESSOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.