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FDA 510(k)

SIS System (Version 5.1.0)

K-Number: K210071 · 2021-03-31

ApplicantSurgical Information Sciences, Inc.
Decision Date2021-03-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIS System (Version 5.1.0) is a medical device manufactured by Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2021-03-31 under approval number K210071. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIS System (Version 5.1.0)?

SIS System (Version 5.1.0) is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Surgical Information Sciences, Inc.. The 510(k) number is K210071.

When was SIS System (Version 5.1.0) approved by the FDA?

SIS System (Version 5.1.0) received FDA 510(k) clearance on 2021-03-31, under approval number K210071.

What company makes SIS System (Version 5.1.0)?

SIS System (Version 5.1.0) is manufactured by Surgical Information Sciences, Inc..

What is the FDA product code for SIS System (Version 5.1.0)?

The FDA product code for SIS System (Version 5.1.0) is LLZ.

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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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