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FDA 510(k)

Co-Ablation System with Sterile Co-Ablation Probe

K-Number: K243042 · 2025-01-29

ApplicantHygea Medical Technology Co., Ltd.
Decision Date2025-01-29
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Co-Ablation System with Sterile Co-Ablation Probe is a medical device manufactured by Hygea Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-29 under approval number K243042. 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 Co-Ablation System with Sterile Co-Ablation Probe?

Co-Ablation System with Sterile Co-Ablation Probe is a medical device that received FDA 510(k) clearance on 2025-01-29. It is manufactured by Hygea Medical Technology Co., Ltd.. The 510(k) number is K243042.

When was Co-Ablation System with Sterile Co-Ablation Probe approved by the FDA?

Co-Ablation System with Sterile Co-Ablation Probe received FDA 510(k) clearance on 2025-01-29, under approval number K243042.

What company makes Co-Ablation System with Sterile Co-Ablation Probe?

Co-Ablation System with Sterile Co-Ablation Probe is manufactured by Hygea Medical Technology Co., Ltd..

What is the FDA product code for Co-Ablation System with Sterile Co-Ablation Probe?

The FDA product code for Co-Ablation System with Sterile Co-Ablation Probe is GEH.

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: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

Other Devices by Hygea Medical Technology Co., Ltd.

K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

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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.

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