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) (10)

Premarket Exempt

Clear

ENCOR® - 00801741086182 Catalog Number : ECCOAXCAN10G

Device Description : ENCOR® Breast Biopsy System 10 Ga Probe Introducer

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086199 Catalog Number : ECCOAXCAN12G

Device Description : ENCOR® Breast Biopsy System 12 Ga Probe Introducer

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086229 Catalog Number : ECMRINTLOC

Device Description : ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 10G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086236 Catalog Number : ECMRINTLOC7G

Device Description : ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 7G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086243 Catalog Number : ECP0110G

Device Description : ENCOR® Probe Stereotactic/Ultrasound 10G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086250 Catalog Number : ECP0110GV

Device Description : ENCOR® Probe Stereotactic/Ultrasound 10GV Upright

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086267 Catalog Number : ECP0112G

Device Description : ENCOR® Probe Stereotactic/Ultrasound 12G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086274 Catalog Number : ECP0112GV

Device Description : ENCOR® Probe Stereotactic/Ultrasound 12GV Upright

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086281 Catalog Number : ECP017G

Device Description : ENCOR® Probe Stereotactic/Ultrasound 7G

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

ENCOR® - 00801741086298 Catalog Number : ECP017GV

Device Description : ENCOR® Probe Stereotactic/Ultrasound 7GV Upright

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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