FDA 510(k)

MMD Tip

K-Number: K181480 · 2018-08-01

Decision Date2018-08-01

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MMD Tip is a medical device manufactured by Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2018-08-01 under approval number K181480. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MMD Tip?

MMD Tip is a medical device that received FDA 510(k) clearance on 2018-08-01. It is manufactured by Strata Skin Sciences, Inc.. The 510(k) number is K181480.

When was MMD Tip approved by the FDA?

MMD Tip received FDA 510(k) clearance on 2018-08-01, under approval number K181480.

What company makes MMD Tip?

MMD Tip is manufactured by Strata Skin Sciences, Inc..

What is the FDA product code for MMD Tip?

The FDA product code for MMD Tip is GEX. This falls under the Gastroenterology category.

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Official Source

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