Cryolyzer Alpha
FDA 510(k) K760353 · Pilling Co.
510(k) numberK760353
Submission
- Device name
- Cryolyzer Alpha
- Applicant
- Pilling Co.
Mchenry, IL, US - Received
- August 2, 1976
- Decision date
- October 29, 1976
- 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
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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 |
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| K925370 | Triangular Jaw Microlaryngeal ForcepsELW · Traditional | 03/18/1993SE |
| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | 11/21/1991SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
Questions and answers
When was Cryolyzer Alpha cleared by the FDA?
Cryolyzer Alpha (K760353) received a 510(k) decision of Substantially Equivalent on October 29, 1976, 88 days after the submission was received.
What is the product code of K760353?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.