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FDA 510(k)

TCM ENDO V, MODEL 1534

K-Number: K042822 · 2004-12-22

ApplicantNOUVAG AG
Decision Date2004-12-22
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TCM ENDO V, MODEL 1534 is the device name listed in this FDA 510(k) record. The listed applicant is NOUVAG AG. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K042822. 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 TCM ENDO V, MODEL 1534?

TCM ENDO V, MODEL 1534 is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is NOUVAG AG. The 510(k) number is K042822.

When did TCM ENDO V, MODEL 1534 receive FDA 510(k) clearance?

TCM ENDO V, MODEL 1534 received FDA 510(k) clearance on 2004-12-22, under 510(k) number K042822.

Who is the listed applicant for TCM ENDO V, MODEL 1534?

The FDA 510(k) record lists NOUVAG AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCM ENDO V, MODEL 1534?

The FDA product code for TCM ENDO V, MODEL 1534 is EKX.

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Other records listing NOUVAG AG 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.

K254135LipoSurg ARTISTK080365MORCE POWER PLUS AND VARIOCARVE MORCELLATORK081191TCM ENDO 20K071588DISPENSER DP 20K042943NOUVAG AG - VACUSON 40 AND VACUSON 60K042434MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55

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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.

K261987Reusable SmartPegOsstell ABK252223Alpha 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.

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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