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510(k) K181367

Tenex Health TX System with the TXP MicroTip by Tenex Health, Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2018
Date Received
May 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Tenex Health, Inc.

  • K153299 — Tenex Health TX System (March 3, 2016)
  • K123640 — TX1 TISSUE REMOVAL SYSTEM (March 20, 2013)

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