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)

FLEX Microwave Ablation System and Accessories

K-Number: K163118 · 2017-03-09

ApplicantNeuwave Medical, Inc.
Decision Date2017-03-09
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLEX Microwave Ablation System and Accessories is a medical device manufactured by Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2017-03-09 under approval number K163118. 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 FLEX Microwave Ablation System and Accessories?

FLEX Microwave Ablation System and Accessories is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by Neuwave Medical, Inc.. The 510(k) number is K163118.

When was FLEX Microwave Ablation System and Accessories approved by the FDA?

FLEX Microwave Ablation System and Accessories received FDA 510(k) clearance on 2017-03-09, under approval number K163118.

What company makes FLEX Microwave Ablation System and Accessories?

FLEX Microwave Ablation System and Accessories is manufactured by Neuwave Medical, Inc..

What is the FDA product code for FLEX Microwave Ablation System and Accessories?

The FDA product code for FLEX Microwave Ablation System and Accessories is NEY.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING

Related PubMed Literature

PMID: 41517921 Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. Journal of cardiovascular electrophysiology (2026)

Other Devices by Neuwave Medical, Inc.

K161285Ablation Confirmation K160936Certus 140 2.45GHz Ablation System K171022Ablation Confirmation K173756Certus 140 2.45GHz Ablation System K192427Ablation Confirmation K200081NEUWAVE Microwave Ablation System and Accessories

View all 10 devices →

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. K173756Certus 140 2.45GHz Ablation SystemNeuwave 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.

↑