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)

Microwave Ablation Generator (KY-2000A, KY-2100A)

K-Number: K241827 · 2024-09-26

ApplicantCanyon Medical, Inc.
Decision Date2024-09-26
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Microwave Ablation Generator (KY-2000A, KY-2100A) is a medical device manufactured by Canyon Medical, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K241827. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microwave Ablation Generator (KY-2000A, KY-2100A)?

Microwave Ablation Generator (KY-2000A, KY-2100A) is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Canyon Medical, Inc.. The 510(k) number is K241827.

When was Microwave Ablation Generator (KY-2000A, KY-2100A) approved by the FDA?

Microwave Ablation Generator (KY-2000A, KY-2100A) received FDA 510(k) clearance on 2024-09-26, under approval number K241827.

What company makes Microwave Ablation Generator (KY-2000A, KY-2100A)?

Microwave Ablation Generator (KY-2000A, KY-2100A) is manufactured by Canyon Medical, Inc..

What is the FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A)?

The FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A) is NEY.

Related Clinical Trials

NCT05053555 High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies RECRUITING NCT03775980 CIRSE Emprint Microwave Ablation Registry COMPLETED NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT07226869 Computer Guided Microwave Liver Ablation RECRUITING NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING

Other Devices by Canyon Medical, Inc.

K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle K241825Microwave Ablation Antennas K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle K250209Polyvinyl Alcohol Embolic Microspheres

Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave 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.

↑