Cryocare CS Surgical System

FDA 510(k) K153489 · Healthtronics

Substantially Equivalent

510(k) numberK153489

Submission

Device name
Cryocare CS Surgical System
Applicant
Healthtronics
Austin, TX, US
Received
December 4, 2015
Decision date
February 5, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GEH – Unit, Cryosurgical, Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4350
Specialty
General, Plastic Surgery

Other 510(k)s with product code GEH

510(k)DeviceApplicantDecision
K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional Serpex Medical09/02/2026SE
K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional Serpex Medical06/30/2026SE
K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special Erbe Elektromedizin GmbH06/09/2026SE
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional Erbe Elektromedizin GmbH04/22/2026SE
K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional Medical Brands Laboratories B.V.04/02/2026SE
K260377XSense Cryoablation System with CryoProbesGEH · Special IceCure Medical , Ltd.02/24/2026SE
K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional Medinice S.A.02/13/2026SE
K251524Dr. Yglo Skin Tag RemoverGEH · Traditional Theotclab Healthcare B.V.01/12/2026SE
K250742Focused Cryotherapy SystemGEH · Traditional Focused Cryo, Inc.12/09/2025SE
K253114TargetCool™ (RM-DT02W)GEH · Special Recensmedical, Inc.10/16/2025SE

More from Recensmedical, Inc.

510(k)DeviceDecision
K151968Cryocare CS-3 Surgical System version 5GEH · Traditional 09/09/2015SE
K141110Cryocare CS Surgical SystemGEH · Traditional 06/25/2015SE
K021775LTFS230LNS · Traditional 12/23/2002SE

Questions and answers

When was Cryocare CS Surgical System cleared by the FDA?

Cryocare CS Surgical System (K153489) received a 510(k) decision of Substantially Equivalent on February 5, 2016, 63 days after the submission was received.

What is the product code of K153489?

The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.