FDA 510(k)

CushionCast Moldable Cushions

K-Number: K162265 · 2016-11-15

Decision Date2016-11-15

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CushionCast Moldable Cushions is a medical device manufactured by Izi Medical Products, LLC. It received FDA 510(k) clearance on 2016-11-15 under approval number K162265. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CushionCast Moldable Cushions?

CushionCast Moldable Cushions is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Izi Medical Products, LLC. The 510(k) number is K162265.

When was CushionCast Moldable Cushions approved by the FDA?

CushionCast Moldable Cushions received FDA 510(k) clearance on 2016-11-15, under approval number K162265.

What company makes CushionCast Moldable Cushions?

CushionCast Moldable Cushions is manufactured by Izi Medical Products, LLC.

What is the FDA product code for CushionCast Moldable Cushions?

The FDA product code for CushionCast Moldable Cushions is IYE.

Other Devices by Izi Medical Products, LLC

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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.