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)

MEG-TORQ

K-Number: K161500 · 2017-02-22

ApplicantMicro-Nx Co., Ltd.
Decision Date2017-02-22
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEG-TORQ is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K161500. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEG-TORQ?

MEG-TORQ is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K161500.

When did MEG-TORQ receive FDA 510(k) clearance?

MEG-TORQ received FDA 510(k) clearance on 2017-02-22, under 510(k) number K161500.

Who is the listed applicant for MEG-TORQ?

The FDA 510(k) record lists Micro-Nx Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEG-TORQ?

The FDA product code for MEG-TORQ is EKX.

Other records listing Micro-Nx Co., Ltd. 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.

K231562ELEC ENGINE (Model: ISE-170L)K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitK220577Dental Handpiece, Model CA160, CA160L, and CA500LK201191ELEC-LEDK201192Impla-NX (Model: ISE-270M)K192809Dental Handpiece

View all 7 devices →

Related Devices (Code: EKX)

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.

K252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.K243911HPR Cordless Hygiene HandpieceHandpiece Headquarters

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.

↑