C2 CryoBalloon EndoGrip

Endoscopic Irrigation/suction System

PENTAX Medical, A Division Of PENTAX Of America, Inc.

The following data is part of a premarket notification filed by Pentax Medical, A Division Of Pentax Of America, Inc. with the FDA for C2 Cryoballoon Endogrip.

Pre-market Notification Details

Device IDK193036
501k NumberK193036
Device Name:C2 CryoBalloon EndoGrip
ClassificationEndoscopic Irrigation/suction System
Applicant PENTAX Medical, A Division Of PENTAX Of America, Inc. 303 Convention Way, Suite 1 Redwood City,  CA  94063
ContactGurvinder Singh Nanda
CorrespondentGurvinder Singh Nanda
PENTAX Medical, A Division Of PENTAX Of America, Inc. 303 Convention Way, Suite 1 Redwood City,  CA  94063
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-31
Decision Date2019-11-22

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