GEH · Unit, Cryosurgical, Accessories · Chrysalis Intelligence

Device class

Class II

Regulation 878.4350

Total clearances

2020-01-07 → 2026-06-30

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4350

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Recensmedical, Inc.	6	2	2025-10-16
Cryosurgery, Inc.	5	2	2025-10-16
Cryoconcepts LP	5	0	2025-05-22
Boston Scientific	4	0	2024-10-18
Erbe Elektromedizin GmbH	3	2	2026-06-09
Varian Medical Systems, Inc.	3	0	2023-03-28
Pentax of America, Inc.	3	0	2024-07-24
Theotclab Healthcare B.V.	2	1	2026-01-12
Medical Brands Laboratories B.V.	2	1	2026-04-02
STERIS Corporation	2	0	2022-12-02
IceCure Medical , Ltd.	2	1	2026-02-24
CSA Medical, Inc.	1	0	2020-12-07
Yozma Bmtech Co., Ltd.	1	0	2020-05-28
Medinux (Tianjin) Technologies Co., Ltd.	1	0	2023-11-27
Endocision Technologies, Inc.	1	0	2024-09-24
Hygea Medical Technology Co., Ltd.	1	0	2025-01-29
Medinice S.A.	1	1	2026-02-13
Galil Medical, Inc.	1	0	2020-11-02
Serpex Medical	1	1	2026-06-30
Pronova Laboratories BV	1	0	2021-01-21
Medilink A/S	1	0	2021-07-07
Nuance Medical, LLC	1	0	2021-10-22
Dgi Technologies	1	0	2023-05-18
Medtech Products, Inc.	1	0	2024-11-06
Bibawo Medical A/S	1	0	2023-05-30

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
99070	CPT	—	Medium	Cryosurgical unit accessories typically billed as surgical supplies with cryosurgery procedure code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-30	K261068	Serpex Medical	Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
2026-06-09	K261806	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit and Accessories
2026-04-22	K253230	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
2026-04-02	K252198	Medical Brands Laboratories B.V.	Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
2026-02-24	K260377	IceCure Medical , Ltd.	XSense Cryoablation System with CryoProbes
2026-02-13	K251928	Medinice S.A.	CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
2026-01-12	K251524	Theotclab Healthcare B.V.	Dr. Yglo Skin Tag Remover
2025-12-09	K250742	Focused Cryo, Inc.	Focused Cryotherapy System
2025-10-16	K253114	Recensmedical, Inc.	TargetCool (RM-DT02W)
2025-10-16	K253000	Cryosurgery, Inc.	CryoFreeze Wart and Skin Tag Remover
2025-10-15	K253348	Recensmedical, Inc.	TargetCool-e
2025-10-10	K252903	Cryosurgery, Inc.	Verruca-Freeze H Plus
2025-05-22	K251493	Cryoconcepts LP	Skin Clinic Freeze Point for Warts and Skin Tags
2025-04-15	K242932	Cryoconcepts LP	Skin Clinic Nitro Clear Wart Remover
2025-03-13	K243487	Cryosurgery, Inc.	CryoFreeze Wart and Skin Tag Remover
2025-01-29	K243042	Hygea Medical Technology Co., Ltd.	Co-Ablation System with Sterile Co-Ablation Probe
2025-01-21	K242288	Medical Brands Laboratories B.V.	Advanced Cryo Wart Remover
2024-12-03	K243454	Cryosurgery, Inc.	Verruca-Freeze H
2024-11-06	K242803	Medtech Products, Inc.	Compound W Skin Tag Remover
2024-10-25	K242625	Cryoconcepts LP	Freeze Point & Private Label Versions
2024-10-18	K243245	Boston Scientific Corp	IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
2024-09-24	K240776	Endocision Technologies, Inc.	Celsio Flexible Cryocatheter System
2024-07-24	K240457	Pentax of America, Inc.	C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
2024-06-28	K240892	IceCure Medical , Ltd.	XSense Cryoablation System with Cryoprobes
2024-06-10	K240106	Cryoconcepts LP	Histofreezer V