FDA 510(k)

IRISeg

K-Number: K251763 · 2025-12-16

Decision Date2025-12-16

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IRISeg is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-12-16 under approval number K251763. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRISeg?

IRISeg is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K251763.

When was IRISeg approved by the FDA?

IRISeg received FDA 510(k) clearance on 2025-12-16, under approval number K251763.

What company makes IRISeg?

IRISeg is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for IRISeg?

The FDA product code for IRISeg is QIH.

Other Devices by Intuitive Surgical, Inc.

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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.