Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
FDA 510(k) K152329 · C2 Therapeutics, Inc.
510(k) numberK152329
Submission
- Device name
- Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
- Applicant
- C2 Therapeutics, Inc.
Redwood, Ca, CA, US - Received
- August 18, 2015
- Decision date
- April 13, 2016
- 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 |
|---|---|---|
| K163684 | C2 CryoBalloon Ablation SystemGEH · Traditional | 01/23/2018SE |
| K161202 | C2 Cryoballoon Ablation SystemGEH · Traditional | 01/05/2017SE |
| K160994 | C2 CryoBalloon Focal Pear CatheterGEH · Special | 05/19/2016SE |
| K153541 | Coldplay CryoBalloon® Ablation SystemGEH · Special | 01/07/2016SE |
| K152140 | Boa Endoscopic ValveOCX · Traditional | 10/13/2015SE |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemGEH · Special | 07/07/2015SE |
| K150083 | Sidecar External Working ChannelFED · Traditional | 04/14/2015SE |
| K131523 | Cryoballoon Focal Ablation SystemGEH · Special | 08/22/2013SE |
| K101825 | Cryoballoon Ablation SystemGEH · Traditional | 09/29/2010SE |
Questions and answers
When was Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System cleared by the FDA?
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (K152329) received a 510(k) decision of Substantially Equivalent on April 13, 2016, 239 days after the submission was received.
What is the product code of K152329?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.