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FDA 510(k)

Tenex Health TX System with the TXP MicroTip

K-Number: K181367 · 2018-08-28

Decision Date2018-08-28
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Tenex Health TX System with the TXP MicroTip is the device name listed in this FDA 510(k) record. The listed applicant is Tenex Health, Inc.. It received FDA 510(k) clearance on 2018-08-28 under 510(k) 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. The listed applicant is Tenex Health, Inc.. The 510(k) number is K181367.

When did Tenex Health TX System with the TXP MicroTip receive FDA 510(k) clearance?

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

Who is the listed applicant for Tenex Health TX System with the TXP MicroTip?

The FDA 510(k) record lists Tenex Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Tenex Health, Inc. 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.

Related Devices (Code: LFL)

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.

Official Source

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