SENORX, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

INSTRUMENT, BIOPSY (KNW) (8) CLIP, IMPLANTABLE (FZP) (1) MARKER, RADIOGRAPHIC, IMPLANTABLE (NEU) (1)

Premarket Exempt

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StarchMark® UltraCor™ Breast Tissue Marker - 00801741032196 Catalog Number : STMK14GSS

Device Description : STARCHMARK® ULTRACOR™ Breast Tissue Marker, 14 Ga, SS “V”

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

UltraCor® Breast Tissue Marker - 00801741032202 Catalog Number : UCTC17GSS

Device Description : ULTRACOR® Breast Tissue Marker, SS "Coil"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

ENCOR ENSPIRE® - 00801741085956 Catalog Number : AC4001

Device Description : ENCOR ENSPIRE® Breast Biopsy System Driver Holder

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086052 Catalog Number : CM3000

Device Description : ENCOR® Breast Biopsy System Control Module

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086076 Catalog Number : DRENCOR

Device Description : ENCOR® Breast Biopsy System Driver

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086083 Catalog Number : DRENCORMR

Device Description : ENCOR® Breast Biopsy System MRI Driver

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR ENSPIRE® - 00801741086090 Catalog Number : DS4001

Device Description : ENCOR ENSPIRE® Breast Biopsy System Vacuum and Rinse Tubing Cassette

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR ENSPIRE® - 00801741086106 Catalog Number : DS4002

Device Description : ENCOR ENSPIRE® Breast Biopsy System Vacuum Tubing Cassette

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR ENSPIRE® - 00801741086113 Catalog Number : E4115

Device Description : ENCOR ENSPIRE® Breast Biopsy System

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR ULTRA® - 00801741086137 Catalog Number : E5115

Device Description : ENCOR ULTRA® Breast Biopsy System

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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