TX1 TISSUE REMOVAL SYSTEM

Instrument, Ultrasonic Surgical

TENEX HEALTH

The following data is part of a premarket notification filed by Tenex Health with the FDA for Tx1 Tissue Removal System.

Pre-market Notification Details

Device IDK123640
510k NumberK123640
Device Name:TX1 TISSUE REMOVAL SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant TENEX HEALTH 26902 VISTA TERRACE Lake Forest,  CA  92630
ContactDavid Salzberg
CorrespondentDavid Salzberg
TENEX HEALTH 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 Received2012-11-26
Decision Date2013-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857156006246 K123640 000
00857156006086 K123640 000
00857156006208 K123640 000
00857156006222 K123640 000
00857156006260 K123640 000
00857156006277 K123640 000
00857156006291 K123640 000
00857156006307 K123640 000
00857156006314 K123640 000
00857156006321 K123640 000
00857156006352 K123640 000

Trademark Results [TX1 TISSUE REMOVAL SYSTEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TX1 TISSUE REMOVAL SYSTEM
TX1 TISSUE REMOVAL SYSTEM
85599103 not registered Dead/Abandoned
Tenex Health, Inc.
2012-04-16

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