FDA 510(k)

Endo SmartCap

K-Number: K223040 · 2023-03-01

Decision Date2023-03-01

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Endo SmartCap is a medical device manufactured by Medivators, Inc.. It received FDA 510(k) clearance on 2023-03-01 under approval number K223040. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endo SmartCap?

Endo SmartCap is a medical device that received FDA 510(k) clearance on 2023-03-01. It is manufactured by Medivators, Inc.. The 510(k) number is K223040.

When was Endo SmartCap approved by the FDA?

Endo SmartCap received FDA 510(k) clearance on 2023-03-01, under approval number K223040.

What company makes Endo SmartCap?

Endo SmartCap is manufactured by Medivators, Inc..

What is the FDA product code for Endo SmartCap?

The FDA product code for Endo SmartCap is FAJ.

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Related Devices (Code: FAJ)

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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.