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FDA 510(k)

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

K-Number: K192389 · 2020-03-27

ApplicantMedtronic, Inc.
Decision Date2020-03-27
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2020-03-27 under approval number K192389. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)?

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) is a medical device that received FDA 510(k) clearance on 2020-03-27. It is manufactured by Medtronic, Inc.. The 510(k) number is K192389.

When was TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) approved by the FDA?

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) received FDA 510(k) clearance on 2020-03-27, under approval number K192389.

What company makes TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)?

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) is manufactured by Medtronic, Inc..

What is the FDA product code for TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)?

The FDA product code for TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) is FTL.

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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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