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

FDA 510(k)

CryoVIVE

K-Number: K203481 · 2021-05-13

ApplicantRecensmedical, Inc.
Decision Date2021-05-13
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoVIVE is a medical device manufactured by Recensmedical, Inc.. It received FDA 510(k) clearance on 2021-05-13 under approval number K203481. 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 CryoVIVE?

CryoVIVE is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Recensmedical, Inc.. The 510(k) number is K203481.

When was CryoVIVE approved by the FDA?

CryoVIVE received FDA 510(k) clearance on 2021-05-13, under approval number K203481.

What company makes CryoVIVE?

CryoVIVE is manufactured by Recensmedical, Inc..

What is the FDA product code for CryoVIVE?

The FDA product code for CryoVIVE is GEH.

Other Devices by Recensmedical, Inc.

K221234TargetCool K220674TargetCool K230599TargetCool™ DEN230011OcuCool K253114TargetCool™ (RM-DT02W) K253348TargetCool-e

View all 7 devices →

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

View on FDA Database →

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

↑