Medical Device Manufacturer · US , West Cadwell , NJ

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

44 submissions · 44 cleared · Since 2012

Recent clearances: PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family), PENTAX Medical Video Processor (EPK-i8020c), PENTAX Medical Video Colonoscope (EC38-i20cWL)

44

Total

44

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pentax of America, Inc. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Jul 24, 2024

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

General & Plastic Surgery · 159d

Cleared Nov 29, 2021

C2 CryoBalloon Ablation System

General & Plastic Surgery · 87d

Cleared Nov 24, 2020

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2...

General & Plastic Surgery · 53d