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FDA 510(k)

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

K-Number: K233140 · 2024-01-31

ApplicantHygea Medical Technology Co., Ltd.
Decision Date2024-01-31
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is a medical device manufactured by Hygea Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under approval number K233140. 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 Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is a medical device that received FDA 510(k) clearance on 2024-01-31. It is manufactured by Hygea Medical Technology Co., Ltd.. The 510(k) number is K233140.

When was Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) approved by the FDA?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) received FDA 510(k) clearance on 2024-01-31, under approval number K233140.

What company makes Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is manufactured by Hygea Medical Technology Co., Ltd..

What is the FDA product code for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

The FDA product code for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is NEY.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Hygea Medical Technology Co., Ltd.

K243042Co-Ablation System with Sterile Co-Ablation Probe

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.

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