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)

CryOmega Flexx

K-Number: K172769 · 2017-11-30

ApplicantCryoconcepts LP
Decision Date2017-11-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryOmega Flexx is the device name listed in this FDA 510(k) record. The listed applicant is Cryoconcepts LP. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K172769. 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 CryOmega Flexx?

CryOmega Flexx is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Cryoconcepts LP. The 510(k) number is K172769.

When did CryOmega Flexx receive FDA 510(k) clearance?

CryOmega Flexx received FDA 510(k) clearance on 2017-11-30, under 510(k) number K172769.

Who is the listed applicant for CryOmega Flexx?

The FDA 510(k) record lists Cryoconcepts LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryOmega Flexx?

The FDA product code for CryOmega Flexx is GEH.

Other records listing Cryoconcepts LP as applicant

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.

K251493Skin Clinic Freeze Point for Warts and Skin TagsK242932Skin Clinic Nitro Clear Wart RemoverK242625Freeze Point & Private Label VersionsK240106Histofreezer VK211099Freeze’n Clear Skin Clinic Warts & TagsK190407CryoLab

View all 8 devices →

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.

K261068Maverix 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.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

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.

↑