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FDA 510(k)

SIS System (Version 5.6.0)

K-Number: K223032 · 2022-11-21

ApplicantSurgical Information Sciences, Inc.
Decision Date2022-11-21
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIS System (Version 5.6.0) is a medical device manufactured by Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2022-11-21 under approval number K223032. 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 SIS System (Version 5.6.0)?

SIS System (Version 5.6.0) is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Surgical Information Sciences, Inc.. The 510(k) number is K223032.

When was SIS System (Version 5.6.0) approved by the FDA?

SIS System (Version 5.6.0) received FDA 510(k) clearance on 2022-11-21, under approval number K223032.

What company makes SIS System (Version 5.6.0)?

SIS System (Version 5.6.0) is manufactured by Surgical Information Sciences, Inc..

What is the FDA product code for SIS System (Version 5.6.0)?

The FDA product code for SIS System (Version 5.6.0) is QIH.

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Other Devices by Surgical Information Sciences, 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.

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