FDA 510(k)

CryoDose H or Similar

K-Number: K161337 · 2016-07-12

Decision Date2016-07-12

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CryoDose H or Similar is a medical device manufactured by Nuance Medical, LLC. It received FDA 510(k) clearance on 2016-07-12 under approval 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. It is manufactured by Nuance Medical, LLC. The 510(k) number is K161337.

When was CryoDose H or Similar approved by the FDA?

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

What company makes CryoDose H or Similar?

CryoDose H or Similar is manufactured by Nuance Medical, LLC.

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

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

Other Devices by Nuance Medical, LLC

K162218Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit K232674PainFreeze II

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

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.