Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CRYOLYZER ALPHA (CRYOSURG.EQUIP.)

K-Number: K760686 · 1976-11-01

ApplicantCryo-Labs, Inc.
Decision Date1976-11-01
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOLYZER ALPHA (CRYOSURG.EQUIP.) is the device name listed in this FDA 510(k) record. The listed applicant is Cryo-Labs, Inc.. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760686. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOLYZER ALPHA (CRYOSURG.EQUIP.)?

CRYOLYZER ALPHA (CRYOSURG.EQUIP.) is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Cryo-Labs, Inc.. The 510(k) number is K760686.

When did CRYOLYZER ALPHA (CRYOSURG.EQUIP.) receive FDA 510(k) clearance?

CRYOLYZER ALPHA (CRYOSURG.EQUIP.) received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760686.

Who is the listed applicant for CRYOLYZER ALPHA (CRYOSURG.EQUIP.)?

The FDA 510(k) record lists Cryo-Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOLYZER ALPHA (CRYOSURG.EQUIP.)?

The FDA product code for CRYOLYZER ALPHA (CRYOSURG.EQUIP.) is GEH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑