CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
FDA 510(k) K210310 · Nuance Medical, LLC
510(k) numberK210310
Submission
- Device name
- CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
- Applicant
- Nuance Medical, LLC
Carlsbad, CA, US - Received
- February 3, 2021
- Decision date
- October 22, 2021
- 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
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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 |
|---|---|---|
| K232674 | PainFreeze IIMLY · Traditional | 02/12/2024SE |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayMLY · Traditional | 10/18/2017SE |
| K162218 | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102MLY · Traditional | 11/22/2016SE |
| K161337 | CryoDose H or SimilarGEH · Traditional | 07/12/2016SE |
| K130995 | Nuance Cryo-Freeze Spray or Cryo-In-A-Can or Vandolay Freeze SprayGEH · Traditional | 06/14/2013SE |
Questions and answers
When was CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit cleared by the FDA?
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit (K210310) received a 510(k) decision of Substantially Equivalent on October 22, 2021, 261 days after the submission was received.
What is the product code of K210310?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.