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FDA 510(k)

CanGaroo RM Antibacterial Envelope

K-Number: K233991 · 2024-06-14

ApplicantElutia, Inc.
Decision Date2024-06-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CanGaroo RM Antibacterial Envelope is a medical device manufactured by Elutia, Inc.. It received FDA 510(k) clearance on 2024-06-14 under approval number K233991. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CanGaroo RM Antibacterial Envelope?

CanGaroo RM Antibacterial Envelope is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Elutia, Inc.. The 510(k) number is K233991.

When was CanGaroo RM Antibacterial Envelope approved by the FDA?

CanGaroo RM Antibacterial Envelope received FDA 510(k) clearance on 2024-06-14, under approval number K233991.

What company makes CanGaroo RM Antibacterial Envelope?

CanGaroo RM Antibacterial Envelope is manufactured by Elutia, Inc..

What is the FDA product code for CanGaroo RM Antibacterial Envelope?

The FDA product code for CanGaroo RM Antibacterial Envelope is FTM.

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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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