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FDA 510(k)

Tenex Health TX System with the TXP MicroTip

K-Number: K181367 · 2018-08-28

ApplicantTenex Health, Inc.
Decision Date2018-08-28
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Tenex Health TX System with the TXP MicroTip is a medical device manufactured by Tenex Health, Inc.. It received FDA 510(k) clearance on 2018-08-28 under approval number K181367. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tenex Health TX System with the TXP MicroTip?

Tenex Health TX System with the TXP MicroTip is a medical device that received FDA 510(k) clearance on 2018-08-28. It is manufactured by Tenex Health, Inc.. The 510(k) number is K181367.

When was Tenex Health TX System with the TXP MicroTip approved by the FDA?

Tenex Health TX System with the TXP MicroTip received FDA 510(k) clearance on 2018-08-28, under approval number K181367.

What company makes Tenex Health TX System with the TXP MicroTip?

Tenex Health TX System with the TXP MicroTip is manufactured by Tenex Health, Inc..

What is the FDA product code for Tenex Health TX System with the TXP MicroTip?

The FDA product code for Tenex Health TX System with the TXP MicroTip is LFL.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Tenex Health, Inc.

K153299Tenex Health TX System

Related Devices (Code: LFL)

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Official Source

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