FDA 510(k)

InstruSafe Instrument Protection System

K-Number: K210836 · 2021-11-30

Decision Date2021-11-30

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

InstruSafe Instrument Protection System is a medical device manufactured by Summitt Medical, LLC. It received FDA 510(k) clearance on 2021-11-30 under approval number K210836. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstruSafe Instrument Protection System?

InstruSafe Instrument Protection System is a medical device that received FDA 510(k) clearance on 2021-11-30. It is manufactured by Summitt Medical, LLC. The 510(k) number is K210836.

When was InstruSafe Instrument Protection System approved by the FDA?

InstruSafe Instrument Protection System received FDA 510(k) clearance on 2021-11-30, under approval number K210836.

What company makes InstruSafe Instrument Protection System?

InstruSafe Instrument Protection System is manufactured by Summitt Medical, LLC.

What is the FDA product code for InstruSafe Instrument Protection System?

The FDA product code for InstruSafe Instrument Protection System is KCT.

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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.