CMS Accuprobe 550/530
FDA 510(k) K953637 · Cryomedical Sciences, Inc.
510(k) numberK953637
Submission
- Device name
- CMS Accuprobe 550/530
- Applicant
- Cryomedical Sciences, Inc.
Rockville, MD, US - Received
- August 2, 1995
- Decision date
- December 4, 1995
- 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 |
| K980670 | CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722GEH · Traditional | 07/17/1998SE |
| 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 |
| K952895 | CMS Urethral WarmerGEH · Traditional | 10/24/1995SE |
| K904421 | CMS Oncoprobe (TM)GEH · Traditional | 04/08/1991SE |
Questions and answers
When was CMS Accuprobe 550/530 cleared by the FDA?
CMS Accuprobe 550/530 (K953637) received a 510(k) decision of Substantially Equivalent on December 4, 1995, 124 days after the submission was received.
What is the product code of K953637?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.