CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722
FDA 510(k) K980670 · Cryomedical Sciences, Inc.
510(k) numberK980670
Submission
- Device name
- CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722
- Applicant
- Cryomedical Sciences, Inc.
Rockville, MD, US - Received
- February 20, 1998
- Decision date
- July 17, 1998
- 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 |
|---|---|---|---|
| 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 |
|---|---|---|
| K011073 | Cryoplan SystemGEH · Traditional | 08/22/2001SE |
| K982055 | Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880GEH · Traditional | 09/08/1998SE |
| K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790GEH · Traditional | 07/17/1998SE |
| K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesGEI · Traditional | 11/21/1997SE |
| K970995 | CMS CryoliteGEH · Traditional | 07/07/1997SE |
| K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680GEH · Traditional | 03/20/1997SE |
| K953637 | CMS Accuprobe 550/530GEH · Traditional | 12/04/1995SE |
| K952895 | CMS Urethral WarmerGEH · Traditional | 10/24/1995SE |
| K904421 | CMS Oncoprobe (TM)GEH · Traditional | 04/08/1991SE |
Questions and answers
When was CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 cleared by the FDA?
CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 (K980670) received a 510(k) decision of Substantially Equivalent on July 17, 1998, 147 days after the submission was received.
What is the product code of K980670?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.