FDA.reportPublic FDA data

Katrine Austin

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30089923123008992312Katrine Austin1N2026-01-01300 E-Business Way Fifth Floor Cincinnati OH US 45241

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1283841173993677K99281311 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULTKNW1999-11-18
1283841936935159K991980MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,KNW1999-08-17
1283841330532888K943863NEEDLE GUIDEIYN1994-12-29
1283841811434448K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharKNW2026-03-04
1283841701589338K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)NEU2026-01-23
1283841846031879K243095Mammotome AutoCore™ Single Insertion Core Biopsy SystemKNW2024-10-29
1283841466872980K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)NEU2024-07-10
1283841800108434K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))NEU2024-01-12
1283841574631595K221961HydroMARK Plus Breast Biopsy Site MarkerNEU2023-07-13
1283841000855910K212158HydroMARK Breast Biopsy Site MarkerNEU2022-04-21
1283841478152752K210752HydroMARK Breast Biopsy Site MarkerNEU2021-04-14
1283841190942246K203097HydroMARK Breast Biopsy Site MarkersNEU2020-12-16
1283841718596960K202012Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemKNW2020-08-18
1283841763558404K161021HydroMARK Breast Biopsy Site MarkerNEU2016-05-05
1283841469699926K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletKNW2016-08-08
1283841317484563K152989Mammotome revolve Dual Vacuum Assist Biopsy SystemKNW2016-02-25
1283841285926494K130537BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKERNEU2013-03-29
1283841744110659K121113BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKERNEU2012-07-12
1283842046568076K093899MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGINGKNW2010-04-29
1283841783340292K082278MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERSNEU2008-12-16
1283841488000926K042753MAMMOTOME MR BIOPSY SYSTEMKNW2004-11-08
1283841311214082K033700MAMMOTOME EX HAND HELD SYSTEMKNW2004-02-20
1283841038925391K0202768 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535NEU2002-04-12
1283841705855620K013413MICROMARK II TISSUE MARKER,MODEL C1535NEU2001-12-03
1283841106882325K003297MAMMOTOME HAND HELD PROBE, MODEL MHH8KNW2001-01-18
1283841137146459
1283841743058668

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEU132026-01-23
KNW112026-03-04
IYN11994-12-29