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FDA 510(k)

CryoDose H or Similar

K-Number: K161337 · 2016-07-12

ApplicantNuance Medical, LLC
Decision Date2016-07-12
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoDose H or Similar is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K161337. 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 CryoDose H or Similar?

CryoDose H or Similar is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Nuance Medical, LLC. The 510(k) number is K161337.

When did CryoDose H or Similar receive FDA 510(k) clearance?

CryoDose H or Similar received FDA 510(k) clearance on 2016-07-12, under 510(k) number K161337.

Who is the listed applicant for CryoDose H or Similar?

The FDA 510(k) record lists Nuance Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoDose H or Similar?

The FDA product code for CryoDose H or Similar is GEH.

Other records listing Nuance Medical, LLC 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.

K232674PainFreeze IIK210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitK172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayK162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102

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

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

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