Cleared Traditional

K180061 - UltraCor Twirl Breast Tissue Marker (FDA 510(k) Clearance)

K180061 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device

Mar 2018

Decision

60d

Days

Class 2

Risk

K180061 is an FDA 510(k) clearance for the UltraCor Twirl Breast Tissue Marker. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on March 9, 2018, 60 days after receiving the submission on January 8, 2018.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K180061 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 08, 2018
Decision Date	March 09, 2018
Days to Decision	60 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF