FDA 510(k)

UltraCor Twirl Breast Tissue Marker

K-Number: K243642 · 2025-03-24

Decision Date2025-03-24

Product CodeNEU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

UltraCor Twirl Breast Tissue Marker is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-03-24 under approval number K243642. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraCor Twirl Breast Tissue Marker?

UltraCor Twirl Breast Tissue Marker is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K243642.

When was UltraCor Twirl Breast Tissue Marker approved by the FDA?

UltraCor Twirl Breast Tissue Marker received FDA 510(k) clearance on 2025-03-24, under approval number K243642.

What company makes UltraCor Twirl Breast Tissue Marker?

UltraCor Twirl Breast Tissue Marker is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for UltraCor Twirl Breast Tissue Marker?

The FDA product code for UltraCor Twirl Breast Tissue Marker is NEU.

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Other Devices by Bard Peripheral Vascular, Inc.

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Related Devices (Code: NEU)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.