Atec Sapphire 100

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: ATEC SAPPHIRE 100 FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: 100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE FDA UDI
Model / Reference: ATEC SAPPHIRE 100 FDA UDI
Description: 100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE FDA UDI

Identifiers

Catalog Number: ATEC SAPPHIRE 100 FDA UDI
Primary DI / UDI-DI: 15420045504028 FDA UDI
510(k) Number: K042290 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Mammographic stereotactic biopsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Mammographic stereotactic biopsy system

Atec Sapphire 100 by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mammographic stereotactic biopsy system.

BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
ENCOR® — SENORX, INC. · Class II
Mammotome — Devicor Medical Products, Inc. · Class II
ENCOR® — SENORX, INC. · Class II
EleVation™ — Bard Peripheral Vascular · Class II
Mammotome elite — Devicor Medical Products, Inc. · Class II
Mammotome revolve — Devicor Medical Products, Inc. · Class II
Mammotome MR — Devicor Medical Products, Inc. · Class II

Cleared under the same submission

K042290 also covers:

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

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Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI 902f4ec0-67ff-4848-ab19-686c7f974272 37 fields · synced May 31, 2026