Affirm Lateral Arm Upright Biopsy Accessory— 510(k) K161575

Name: FDA 510(k) clearance K161575
Creator: U.S. Food and Drug Administration
Published: 2016-08-10

Substantially Equivalent

Hologic

FDA 510(k) clearance K161575 for Affirm Lateral Arm Upright Biopsy Accessory, Substantially Equivalent on 2016-08-10. Applicant: Hologic. Device class: 2.

Clearance details

Applicant: Hologic
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2016-06-07
Decision date: 2016-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K161575

K-number listed on FDA's recall record

Z-0351-2018 — Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880Class II·Terminated·Hologic, Inc.·20170707

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161575.

Data sourced from openFDA. This site is unofficial and independent of the FDA.