C2 CryoBalloon EndoGrip

GUDID 00854924006408

EndoGrip

PENTAX OF AMERICA, INC.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID00854924006408
NIH Device Record Keyd8638dfc-11f6-4475-b831-af09861fbe2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2 CryoBalloon EndoGrip
Version Model NumberFG-1040
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854924006408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-06
Device Publish Date2020-07-29

Devices Manufactured by PENTAX OF AMERICA, INC.

00854924006255 - C2 CryoBalloon Ablation System 2025-04-14 Gen 2 360 Degree Pear Catheter
00854924006293 - C2 CryoBalloon Ablation System2025-04-14 Gen 2 360 Degree Standard Catheter
04961333255313 - C2 CryoBalloon2024-09-20
04961333255320 - C2 CryoBalloon2024-09-20
04961333254309 - MULTI-SPEECH2023-09-04 Multi-Speech Microphone, Condensor
04961333248117 - Pentax of America2022-11-14 Capture Module
04961333248445 - C2 CryoBalloon Nitroclip2020-08-17 NitroClip
00854924006408 - C2 CryoBalloon EndoGrip2020-08-06EndoGrip
00854924006408 - C2 CryoBalloon EndoGrip2020-08-06 EndoGrip

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.