Who else makes this device?

Name: IceSphere™ 1.5 CX Cryoablation Needle
Brand: IceSphere™ 1.5 CX Cryoablation Needle

General & Plastic Surgery › SurgicalUnit, Cryosurgical, Accessories

IceSphere™ 1.5 CX Cryoablation Needle

1.5 mm Cryoablation Needle

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

40recalls on this code

Who Else Makes It

Concentrated in Guangdong (1), Beijing (1), Tianjin (1).

Chinese manufacturers registered for FDA product code GEH
Manufacturer	City	Province	Registered as	Device types
Shenzhen Kesite Digital Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	4
Hygea Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	2
Medinux (Tianjin) Technologies Co., Ltd.	Tianjin	Tianjin	Manufacturer	1

Record

Regulatory record for IceSphere™ 1.5 CX Cryoablation Needle
Listed by	Boston Scientific Corporation, United States
FDA product code	GEH
Device type	Unit, Cryosurgical, Accessories
Device class	Class 2
Regulation	21 CFR 878.4350
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2018-09-22
Record revised	2023-08-09 (version 4)

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Cool, Dry, Place
Sizes	Outer diameter 1.5 mm; shaft length 175 mm

Catalogue Numbers

Catalogue numbers for IceSphere™ 1.5 CX Cryoablation Needle
Catalogue number	Size	Status
FPRPR3573	Outer Diameter 1.5 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Frigitronics	Coopersurgical, Inc.	42
CryoProbe™	H&O Equipments, Nv/Sa	35
Wallach	Coopersurgical, Inc.	32
Premier	Premier Dental Products Co.	30
Hygea	Hygea Medical Technology Co., Ltd.	26
truFreeze	CSA Medical	20
Freezpen®	H&O Equipments, Nv/Sa	19
Leisegang Cryotip for LM-900	Coopersurgical, Inc.	15
Integra® Miltex®	Integra LifeSciences Production Corporation	13
cryoICE Cryoablation System	Atricure, Inc.	13
CryoThin	Medinux (Tianjin) Technologies Co., Ltd.	12
Erbe	Erbe Elektromedizin GmbH	12

Showing 12 of 334. All products under Unit, Cryosurgical, Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243245	2024-10-18
K234002	2024-03-13
K232635	2023-11-22
K230551	2023-08-08
K961219	1996-06-21

Recalls

40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-08-18	Class II	Process control	Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.	1 unit
2025-08-18	Class II	Process control	Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.	18 units
2025-03-24	Class II	Process control	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of a	435 units
2025-03-24	Class II	Process control	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of a	31 units
2025-03-24	Class II	Process control	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of a	67 units
2025-03-24	Class II	Process control	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of a	244 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	211 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	772 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	4,645 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	86 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	525 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	6,363 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	245 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	115 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	419 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	947 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	627 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	8453 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	52 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	26 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	788 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	22,289 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	39 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	243 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	92 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	729 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	255 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	178 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	2,429 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	64 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	1,526 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	117 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	93 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	85 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	152 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	140 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	261 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	262 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	215 units
2020-11-18	Class II	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.	75 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.