truFreeze System
FDA 510(k) K172041 · CSA Medical, Inc.
510(k) numberK172041
Submission
- Device name
- truFreeze System
- Applicant
- CSA Medical, Inc.
Lexington, MA, US - Received
- July 6, 2017
- Decision date
- July 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional | Serpex Medical | 09/02/2026SE |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional | Serpex Medical | 06/30/2026SE |
| K261806 | ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special | Erbe Elektromedizin GmbH | 06/09/2026SE |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | Erbe Elektromedizin GmbH | 04/22/2026SE |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional | Medical Brands Laboratories B.V. | 04/02/2026SE |
| K260377 | XSense Cryoablation System with CryoProbesGEH · Special | IceCure Medical , Ltd. | 02/24/2026SE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional | Medinice S.A. | 02/13/2026SE |
| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
More from Recensmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201183 | Vortex Radial Spray CatheterGEH · Traditional | 12/07/2020SE |
| K171626 | truFreeze SystemGEH · Traditional | 08/30/2017SE |
| K171522 | truFreeze Rapid AV Spray KitGEH · Traditional | 07/14/2017SE |
| K163244 | truFreeze SystemGEH · Traditional | 05/24/2017SE |
| K162695 | truFreeze SystemGEH · Special | 10/25/2016SE |
| K161557 | truFreeze SystemGEH · Traditional | 07/26/2016SE |
| K152668 | truFreeze SystemGEH · Special | 10/14/2015SE |
| K150920 | truFreeze SystemGEH · Traditional | 06/17/2015SE |
| K143625 | truFreeze SystemGEH · Special | 01/15/2015SE |
| K133258 | Trufreeze SystemGEH · Traditional | 06/19/2014SE |
Questions and answers
When was truFreeze System cleared by the FDA?
truFreeze System (K172041) received a 510(k) decision of Substantially Equivalent on July 27, 2017, 21 days after the submission was received.
What is the product code of K172041?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.