SINUS DILATION SYSTEM

Instrument, Ent Manual Surgical

ENTRIGUE SURGICAL, INC.

The following data is part of a premarket notification filed by Entrigue Surgical, Inc. with the FDA for Sinus Dilation System.

Pre-market Notification Details

Device IDK121351
510k NumberK121351
Device Name:SINUS DILATION SYSTEM
ClassificationInstrument, Ent Manual Surgical
Applicant ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 San Antonio,  TX  78249
ContactGabriele G Niederauer, Ph.d.
CorrespondentGabriele G Niederauer, Ph.d.
ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 San Antonio,  TX  78249
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-04
Decision Date2012-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470009729 K121351 000
00817470009521 K121351 000

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