C2 CryoBalloon™ Ablation System Nitroclip

by Pentax Medical a Division of Pentax of America Inc United States EUDAMED510(k)GUDID

Ref FG-1050510(k) K240457 Product code GEHEMDN Z120102

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number4961333020019Y5 Basic UDI-DI	Date2 Oct 2024Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK240457	Date24 Jul 2024Cleared	StatusActive
United States	FDA 510(k) 510(k)	NumberK212814	Date29 Nov 2021Issued	StatusActive
United States	GUDID listing GUDID	Number04961333248445 UDI-DI	Date7 Aug 2020Listed	StatusListed

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Trade Name: C2 CryoBalloon™ Ablation System Nitroclip EUDAMED
C2 CryoBalloon Nitroclip GUDID
Generic Name: General cryosurgical system, cryogen gas, mechanical
Model / Reference: FG-1050

Primary DI / UDI-DI: 04961333248445
Basic UDI-DI: 4961333020019Y5
FDA Product Code: GEH
EMDN Code: Z120102 Cryosurgery equipment
GMDN Term: General cryosurgical system, cryogen gas, mechanical

Device Class: Class I EUDAMED
Class II GUDID
Regulation Number: 878.4350
Market of Registration: Germany
Commercial Distribution: Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device Class	EUDAMED Class I	GUDID Class II

Manufacturer details

EUDAMED SRN: US-MF-000042816
FDA applicant: Pentax of America, Inc.
Authorised representative: PENTAX Europe GmbH DE-AR-000000006

Other devices from Pentax Medical a Division of Pentax of America Inc

C2 Cryoablation(TM) System catheter

Class IIa
C2 CryoBalloon EndoGrip

Class II
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Class II
C2 CryoBalloon(TM) System Controller

Class IIa
C2 CryoBalloon™Ablation system Catheter

Class IIa
C2 Cryoablation(TM) System catheter

Class IIa

See all devices from Pentax Medical a Division of Pentax of America Inc →

Properties & raw data

Show properties, registry sources and raw records

Single Use
Reusable
Prescription Use
Lot / Batch Number

Other properties (20)

Sterile: No
Implantable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No

Sources (3)

EUDAMED 6dc044d6-3c7e-4dce-a00d-9d093504c867 85 fields · synced 22 Oct 2026
FDA UDI d8cd5847-b2b0-4e3c-a651-b6866783a3cd 34 fields · synced 30 May 2026
FDA 510(k) K240457 1 fields · synced 18 May 2026