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) (10) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (2)

Premarket Exempt

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ENCOR® - 00801741086458 Catalog Number : ENCFF02

Device Description : ENCOR® Breast Biopsy System Fire Forward Accessory

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086465 Catalog Number : ENCFINSERT10G

Device Description : ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 10G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086472 Catalog Number : ENCFINSERT12G

Device Description : ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 12G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086489 Catalog Number : ENCFINSERT7G

Device Description : ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 7G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086502 Catalog Number : ENCLRINSERT10G

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

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086519 Catalog Number : ENCLRINSERT12G

Device Description : ENCOR® Breast Biopsy System Needle Guide Insert (Lorad™), 12G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086526 Catalog Number : ENCLRINSERT7G

Device Description : ENCOR® Breast Biopsy System Needle Guide Insert (Lorad™), 7G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086540 Catalog Number : FSENCORMR

Device Description : ENCOR® Breast Biopsy System MRI Footswitch

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : GEI, KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086557 Catalog Number : FSENCOR01

Device Description : ENCOR® Breast Biopsy System Footswitch For use with EnCor® System

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : GEI, KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086670 Catalog Number : RINSETUB

Device Description : ENCOR® Breast Biopsy System Rinse Tubing Set

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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