Decision Date2020-11-10
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
StimSite is the device name listed in this FDA 510(k) record. The listed applicant is Allotrope Medical, Inc.. It received FDA 510(k) clearance on 2020-11-10 under 510(k) 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. The listed applicant is Allotrope Medical, Inc.. The 510(k) number is K200886.
When did StimSite receive FDA 510(k) clearance?
StimSite received FDA 510(k) clearance on 2020-11-10, under 510(k) number K200886.
Who is the listed applicant for StimSite?
The FDA 510(k) record lists Allotrope Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for StimSite?
The FDA product code for StimSite is ETN.
Related Devices (Code: ETN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.