Sanarus Visica Treatment System
FDA 510(k) K022314 · Sanarus Medical, Inc.
510(k) numberK022314
Submission
- Device name
- Sanarus Visica Treatment System
- Applicant
- Sanarus Medical, Inc.
Pleasanton, CA, US - Received
- July 17, 2002
- Decision date
- October 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code GEH
| 510(k) | Device | Applicant | Decision |
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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 |
|---|---|---|
| K080171 | Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012KNW · Traditional | 03/06/2008SE |
| K073533 | Sanarus V2 Treatment SystemGEH · Special | 02/07/2008SE |
| K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600GEH · Traditional | 01/03/2007SE |
| K061510 | Sanarus Visica Treatment SystemGEH · Special | 07/18/2006SE |
| K052861 | Modification To:Sanarus Visica Treatment System , Models VS2000GEH · Special | 11/15/2005SE |
| K051581 | Sanarus Cassi II Rotational Core Biopsy System, Model CS2000KNW · Traditional | 07/27/2005SE |
| K042136 | Sanarus Cassi Rotational Core Biopsy SystemKNW · Special | 09/08/2004SE |
| K032506 | Sanarus Centrica II Rotational Core Biopsy SystemKNW · Traditional | 10/09/2003SE |
| K020054 | Sanarus Indica Marker SystemFZP · Traditional | 10/16/2002SE |
| K022879 | Modification to Sanarus Centrica Core Tissue BiopsyKNW · Special | 09/23/2002SE |
Questions and answers
When was Sanarus Visica Treatment System cleared by the FDA?
Sanarus Visica Treatment System (K022314) received a 510(k) decision of Substantially Equivalent on October 15, 2002, 90 days after the submission was received.
What is the product code of K022314?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.