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)

truFreeze System

K-Number: K160273 · 2016-03-25

ApplicantCsa Medial, Inc.
Decision Date2016-03-25
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

truFreeze System is a medical device manufactured by Csa Medial, Inc.. It received FDA 510(k) clearance on 2016-03-25 under approval number K160273. 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 truFreeze System?

truFreeze System is a medical device that received FDA 510(k) clearance on 2016-03-25. It is manufactured by Csa Medial, Inc.. The 510(k) number is K160273.

When was truFreeze System approved by the FDA?

truFreeze System received FDA 510(k) clearance on 2016-03-25, under approval number K160273.

What company makes truFreeze System?

truFreeze System is manufactured by Csa Medial, Inc..

What is the FDA product code for truFreeze System?

The FDA product code for truFreeze System is GEH.

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.

↑