CCS100 Cryosurgical System
FDA 510(k) K811390 · Frigitronics of Connecticut, Inc.
510(k) numberK811390
Submission
- Device name
- CCS100 Cryosurgical System
- Applicant
- Frigitronics of Connecticut, Inc.
Walker, MI, US - Received
- May 18, 1981
- Decision date
- June 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K891282 | MIC-100 with CryoprobesGEH · Traditional | 06/15/1989SE |
| K872362 | Frigitronics ACC-1000 Capsule CutterHQC · Traditional | 07/27/1987SE |
| K853308 | Keates Irrigation/Aspiration/Vitreous Cutter 5000HQE · Traditional | 10/04/1985SE |
| K834577 | I/A Probe Lines · Traditional | 05/22/1984SE |
| K840536 | Cryo Surg 5900GEH · Traditional | 04/23/1984SE |
| K834437 | Keates Irrigation/Aspiration/VitreousHQE · Traditional | 03/30/1984SE |
| K822599 | Keates I/A System Frigitronics 4000HKP · Traditional | 10/06/1982SE |
| K760742 | CS-76 And/Or Cryocare IGEH · Traditional | 11/03/1976SE |
Questions and answers
When was CCS100 Cryosurgical System cleared by the FDA?
CCS100 Cryosurgical System (K811390) received a 510(k) decision of Substantially Equivalent on June 16, 1981, 29 days after the submission was received.
What is the product code of K811390?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.