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FDA 510(k)

TX1 TISSUE REMOVAL SYSTEM

K-Number: K123640 · 2013-03-20

ApplicantTenex Health
Decision Date2013-03-20
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

TX1 TISSUE REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tenex Health. It received FDA 510(k) clearance on 2013-03-20 under 510(k) number K123640. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TX1 TISSUE REMOVAL SYSTEM?

TX1 TISSUE REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-20. The listed applicant is Tenex Health. The 510(k) number is K123640.

When did TX1 TISSUE REMOVAL SYSTEM receive FDA 510(k) clearance?

TX1 TISSUE REMOVAL SYSTEM received FDA 510(k) clearance on 2013-03-20, under 510(k) number K123640.

Who is the listed applicant for TX1 TISSUE REMOVAL SYSTEM?

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

What is the FDA product code for TX1 TISSUE REMOVAL SYSTEM?

The FDA product code for TX1 TISSUE REMOVAL SYSTEM is LFL.

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Related Devices (Code: LFL)

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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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