Tenex Health TX System With The TXP MicroTip

Instrument, Ultrasonic Surgical

Tenex Health, Inc.

The following data is part of a premarket notification filed by Tenex Health, Inc. with the FDA for Tenex Health Tx System With The Txp Microtip.

Pre-market Notification Details

Device IDK181367
510k NumberK181367
Device Name:Tenex Health TX System With The TXP MicroTip
ClassificationInstrument, Ultrasonic Surgical
Applicant Tenex Health, Inc. 26902 Vista Terrace Lake Forest,,  CA  92630
ContactDavid Vancelette
CorrespondentDavid Vancelette
Tenex Health, Inc. 26902 Vista Terrace Lake Forest,,  CA  92630
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-23
Decision Date2018-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857156006123 K181367 000
00857156006338 K181367 000
00857156006109 K181367 000
00857156006079 K181367 000
00857156006406 K181367 000

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