FDA 510(k)

MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs

K-Number: K242963 · 2025-04-24

Decision Date2025-04-24

Product CodeLCJ

DecisionSubstantially Equivalent

Device Summary

MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2025-04-24 under approval number K242963. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs?

MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K242963.

When was MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs approved by the FDA?

MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs received FDA 510(k) clearance on 2025-04-24, under approval number K242963.

What company makes MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs?

MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs is manufactured by Mentor Worldwide, LLC.

What is the FDA product code for MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs?

The FDA product code for MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs is LCJ.

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Related Devices (Code: LCJ)

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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.