SENORX, INC.

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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) (7) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (3)

Premarket Exempt

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ENCOR® - 00801741086304 Catalog Number : ECPMR0110G

Device Description : ENCOR® Probe MRI 10G Trocar Tip

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086311 Catalog Number : ECPMR0110GBT

Device Description : ENCOR® Probe MRI 10G Blunt Tip

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086328 Catalog Number : ECPMR017G

Device Description : ENCOR® Probe MRI 7G Trocar Tip

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

EnCor® - 00801741086373 Catalog Number : ECSTUS0112G

Device Description : EnCor® Ultrasound Stylet and Coaxial, 12G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

EnCor® - 00801741086380 Catalog Number : ECSTUS0110G

Device Description : EnCor® Ultrasound Stylet and Coaxial, 10G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

EnCor® - 00801741086397 Catalog Number : ECSTUS017G

Device Description : EnCor® Ultrasound Stylet and Coaxial, 7G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086403 Catalog Number : ECTRACOVER

Device Description : ENCOR® Breast Biopsy System Sample Trap Tray Cover

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086410 Catalog Number : ECTT

Device Description : ENCOR® Breast Biopsy System Tissue Collection Tray

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086427 Catalog Number : ENCARINSERTMR10G

Device Description : ENCOR® Breast Biopsy System MRI Needle Guide Insert (Aurora™), 10G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086441 Catalog Number : ENCFF01

Device Description : ENCOR® Breast Biopsy System Fire Forward Adapter Accessory

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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