Medical Device Manufacturer · US , West Cadwell , NJ

Pentax of America, Inc. - FDA 510(k) Cleared Devices

44 submissions · 44 cleared · Since 2012
44
Total
44
Cleared
0
Denied

Pentax of America, Inc. has 44 FDA 510(k) cleared medical devices. Based in West Cadwell, US.

Latest FDA clearance: Dec 2025. Active since 2012. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Pentax of America, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Pentax of America, Inc.

44 devices
1-12 of 44
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Gastroenterology & Urology · 237d
Cleared Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
K251127 · PEA
Gastroenterology & Urology · 53d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · FDF
Gastroenterology & Urology · 168d
Cleared Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
K241213 · FDS
Gastroenterology & Urology · 220d
Cleared Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · FDT
Gastroenterology & Urology · 231d
Cleared Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · GEH
General & Plastic Surgery · 159d
Cleared Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
K232860 · EOQ
Ear, Nose, Throat · 125d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
K231970 · EOQ
Ear, Nose, Throat · 193d
Cleared Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249 · ODC
Gastroenterology & Urology · 126d
Cleared Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
K231249 · PEA
Gastroenterology & Urology · 88d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235 · EOQ
Ear, Nose, Throat · 447d
Cleared Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
K223072 · EOX
Ear, Nose, Throat · 63d

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