Encor®

FDA UDI

Class II (US FDA UDI)

by Senorx, Inc.

Identity

Trade Name: ENCOR® FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: ENCOR® Breast Biopsy System Footswitch For use with EnCor® System FDA UDI
Model / Reference: FSENCOR01 FDA UDI
Description: ENCOR® Breast Biopsy System Footswitch For use with EnCor® System FDA UDI

Identifiers

Catalog Number: FSENCOR01 FDA UDI
Primary DI / UDI-DI: 00801741086557 FDA UDI
FDA Product Code: GEI FDA UDI
KNW FDA UDI
GMDN Term: Mammographic stereotactic biopsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mammographic stereotactic biopsy system

Encor® by Senorx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mammographic stereotactic biopsy system.

ATEC SAPPHIRE 100 — Hologic, Inc. · Class II
Brevera Breast Biopsy System — Hologic, Inc. · Class II
BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
Brevera Breast Biopsy System — Hologic, Inc. · Class II
Eviva — Hologic, Inc. · Class I
Mammotome — Devicor Medical Products, Inc. · Class II
Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II
EleVation™ — Bard Peripheral Vascular · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Senorx, Inc.

Sources (1)

FDA UDI 3be13801-eb6c-4300-b06f-f6dfe6cf4f3a 35 fields · synced May 30, 2026