Verruca-Freeze Cryosurgical Delivery System (Modification)
FDA 510(k) K955083 · Cryosurgery, Inc.
510(k) numberK955083
Submission
- Device name
- Verruca-Freeze Cryosurgical Delivery System (Modification)
- Applicant
- Cryosurgery, Inc.
Nashville, TN, US - Received
- September 25, 1995
- Decision date
- February 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K261684 | FreezeSpray TAMLY · Traditional | 09/05/2026SE |
| K253000 | CryoFreeze Wart and Skin Tag RemoverGEH · Special | 10/16/2025SE |
| K252903 | Verruca-Freeze H PlusGEH · Special | 10/10/2025SE |
| K243487 | CryoFreeze Wart and Skin Tag RemoverGEH · Traditional | 03/13/2025SE |
| K243454 | Verruca-Freeze HGEH · Special | 12/03/2024SE |
| K233347 | Verruca-Freeze® HGEH · Traditional | 12/04/2023SE |
| K982506 | Verruca-Freeze Cryosurgery Delivery SystemGEH · Traditional | 01/27/1999SE |
| K944221 | Verruca-Freeze(Tm) Cryosurgical Delivery Syst, ModifiedGEH · Traditional | 12/15/1994SE |
Questions and answers
When was Verruca-Freeze Cryosurgical Delivery System (Modification) cleared by the FDA?
Verruca-Freeze Cryosurgical Delivery System (Modification) (K955083) received a 510(k) decision of Substantially Equivalent on February 8, 1996, 136 days after the submission was received.
What is the product code of K955083?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.