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FDA 510(k)

TCM ENDO III

K-Number: K013185 · 2001-11-28

ApplicantNOUVAG AG
Decision Date2001-11-28
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TCM ENDO III is the device name listed in this FDA 510(k) record. The listed applicant is NOUVAG AG. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K013185. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCM ENDO III?

TCM ENDO III is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is NOUVAG AG. The 510(k) number is K013185.

When did TCM ENDO III receive FDA 510(k) clearance?

TCM ENDO III received FDA 510(k) clearance on 2001-11-28, under 510(k) number K013185.

Who is the listed applicant for TCM ENDO III?

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 III?

The FDA product code for TCM ENDO III is EFA.

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 20K042822TCM ENDO V, MODEL 1534K042943NOUVAG AG - VACUSON 40 AND VACUSON 60

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Related Devices (Code: EFA)

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.

K192809Dental HandpieceMicro-Nx Co., Ltd.K163239SMARTmaticKaltenbach & Voigt GmbHK101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.K090055LOW & HIGH SPEED KITDpm USA Corp.

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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