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) Regulatory Record - 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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