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FDA 510(k)

SiJoin®T3

K-Number: K213815 · 2023-03-29

ApplicantVgi Medical, Inc.
Decision Date2023-03-29
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SiJoin®T3 is a medical device manufactured by Vgi Medical, Inc.. It received FDA 510(k) clearance on 2023-03-29 under approval number K213815. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SiJoin®T3?

SiJoin®T3 is a medical device that received FDA 510(k) clearance on 2023-03-29. It is manufactured by Vgi Medical, Inc.. The 510(k) number is K213815.

When was SiJoin®T3 approved by the FDA?

SiJoin®T3 received FDA 510(k) clearance on 2023-03-29, under approval number K213815.

What company makes SiJoin®T3?

SiJoin®T3 is manufactured by Vgi Medical, Inc..

What is the FDA product code for SiJoin®T3?

The FDA product code for SiJoin®T3 is OUR.

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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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