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

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 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 Oct 20, 2021

PENTAX Medical Video Upper GI Scopes EG17-J10

K210177 · FDS

Gastroenterology & Urology · 271d

Cleared Oct 01, 2021

PENTAX Medical Auto Leakage Tester SHA-P6

K212201 · PCV

Gastroenterology & Urology · 79d

Cleared May 13, 2021

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video...

K210485 · FDS

Gastroenterology & Urology · 83d

Cleared Apr 09, 2021

PENTAX Medical Video Duedenoscope ED34-i10T2

K210710 · FDT

Gastroenterology & Urology · 30d

Cleared Apr 01, 2021

Pentax Medical Video Duodenoscope ED32-i10

K202365 · FDT

Gastroenterology & Urology · 225d