EnCor Breast Biopsy Probe With Rinse Tube

Instrument, Biopsy

SenoRx, Inc.

The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Encor Breast Biopsy Probe With Rinse Tube.

Pre-market Notification Details

Device IDK210654
510k NumberK210654
Device Name:EnCor Breast Biopsy Probe With Rinse Tube
ClassificationInstrument, Biopsy
Applicant SenoRx, Inc. 1625 West 3rd Street Tempe,  AZ  85251
ContactJessica Myer
CorrespondentJessica Myer
SenoRx, Inc. 1625 West 3rd Street Tempe,  AZ  85251
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-04
Decision Date2021-03-31

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