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Affirm Prone Biopsy System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K153486

by Hologic, Inc.

Identity

Trade Name
Affirm Prone Biopsy System FDA UDI
Generic Name
Mammographic stereotactic biopsy system FDA UDI
Device Name
PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM FDA UDI
Model / Reference
ASY-08176 FDA UDI
Description
PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM FDA UDI

Identifiers

Catalog Number
ASY-08176 FDA UDI
Primary DI / UDI-DI
15420045506480 FDA UDI
510(k) Number
K153486 FDA 510(k)FDA UDI
FDA Product Code
IZH FDA 510(k)FDA UDI
GMDN Term
Mammographic stereotactic biopsy system FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1710 FDA 510(k)
Regulation Number
892.1710 FDA 510(k)FDA UDI
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Affirm Prone Biopsy System by Hologic, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (2)

  • FDA 510(k) K153486 24 fields · synced Jun 19, 2026
  • FDA UDI 1a9adb77-b264-4fa3-87e1-abf095c26472 36 fields · synced May 27, 2026