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FDA 510(k)

StimSite

K-Number: K200886 · 2020-11-10

ApplicantAllotrope Medical, Inc.
Decision Date2020-11-10
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

StimSite is a medical device manufactured by Allotrope Medical, Inc.. It received FDA 510(k) clearance on 2020-11-10 under approval number K200886. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StimSite?

StimSite is a medical device that received FDA 510(k) clearance on 2020-11-10. It is manufactured by Allotrope Medical, Inc.. The 510(k) number is K200886.

When was StimSite approved by the FDA?

StimSite received FDA 510(k) clearance on 2020-11-10, under approval number K200886.

What company makes StimSite?

StimSite is manufactured by Allotrope Medical, Inc..

What is the FDA product code for StimSite?

The FDA product code for StimSite is ETN.

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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.

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