UltraCor™ Twirl™ Breast Tissue Marker

by Bard Peripheral Vascular, Inc. 510(k)

Active United States

510(k) K243642

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK243642	Date24 Mar 2025Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

510(k)

510(k) Number: K243642
FDA Product Code: NEU

Device Class: Class II
Regulation: 21 CFR Part 878.4300
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

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