FDA 510(k)

MENTOR MemoryGel Enhance Single Use Gel Sizer

K-Number: K241552 · 2024-09-06

Decision Date2024-09-06

Product CodeMRD

DecisionSubstantially Equivalent

Device Summary

MENTOR MemoryGel Enhance Single Use Gel Sizer is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2024-09-06 under approval number K241552. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR MemoryGel Enhance Single Use Gel Sizer?

MENTOR MemoryGel Enhance Single Use Gel Sizer is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K241552.

When was MENTOR MemoryGel Enhance Single Use Gel Sizer approved by the FDA?

MENTOR MemoryGel Enhance Single Use Gel Sizer received FDA 510(k) clearance on 2024-09-06, under approval number K241552.

What company makes MENTOR MemoryGel Enhance Single Use Gel Sizer?

MENTOR MemoryGel Enhance Single Use Gel Sizer is manufactured by Mentor Worldwide, LLC.

What is the FDA product code for MENTOR MemoryGel Enhance Single Use Gel Sizer?

The FDA product code for MENTOR MemoryGel Enhance Single Use Gel Sizer is MRD.

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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.