Cryocare Surgical System, Model Cryo 20
FDA 510(k) K023757 · Endocare, Inc.
510(k) numberK023757
Submission
- Device name
- Cryocare Surgical System, Model Cryo 20
- Applicant
- Endocare, Inc.
Irvin, CA, US - Received
- November 8, 2002
- Decision date
- December 5, 2002
- 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 |
|---|---|---|
| K101333 | Cryocare CS Surgical SystemGEH · Traditional | 06/14/2010SE |
| K062175 | Cryocare CN2 SystemGEH · Special | 08/28/2006SE |
| K060279 | Cryocare CS Surgical SystemGEH · Special | 02/28/2006SE |
| K050347 | Modification to Cryocare CS Surgical SystemGEH · Traditional | 02/25/2005SE |
| K032333 | Cryocare CS Surgical SystemGEH · Traditional | 08/12/2003SE |
| K021010 | Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEOCL · Special | 06/06/2002SE |
| K020082 | Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery SystemLKY · Special | 02/05/2002SE |
| K011074 | Cryocare Surgical SystemGEH · Traditional | 01/25/2002SE |
| K003811 | Cryocare Surgical SystemGEH · Traditional | 10/11/2001SE |
| K011040 | Cryocare Cardiac Surgical SystemOCL · Traditional | 06/15/2001SE |
Questions and answers
When was Cryocare Surgical System, Model Cryo 20 cleared by the FDA?
Cryocare Surgical System, Model Cryo 20 (K023757) received a 510(k) decision of Substantially Equivalent on December 5, 2002, 27 days after the submission was received.
What is the product code of K023757?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.