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)

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT

K-Number: K113021 · 2012-02-07

ApplicantCSA Medical, Inc.
Decision Date2012-02-07
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is CSA Medical, Inc.. It received FDA 510(k) clearance on 2012-02-07 under 510(k) number K113021. 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 SPRAY KIT?

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT is a medical device that received FDA 510(k) clearance on 2012-02-07. The listed applicant is CSA Medical, Inc.. The 510(k) number is K113021.

When did TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT receive FDA 510(k) clearance?

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT received FDA 510(k) clearance on 2012-02-07, under 510(k) number K113021.

Who is the listed applicant for TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT?

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

What is the FDA product code for TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT?

The FDA product code for TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT is GEH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing CSA Medical, Inc. 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.

K201183Vortex Radial Spray CatheterK171626truFreeze SystemK172041truFreeze SystemK171522truFreeze Rapid AV Spray KitK163244truFreeze SystemK162695truFreeze System

View all 10 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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix 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.

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.

↑