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FDA 510(k)

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)

K-Number: K180122 · 2018-06-07

ApplicantMedtronic, Inc.
Decision Date2018-06-07
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2018-06-07 under approval number K180122. 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 Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)?

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Medtronic, Inc.. The 510(k) number is K180122.

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

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) received FDA 510(k) clearance on 2018-06-07, under approval number K180122.

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

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

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

The FDA product code for TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro 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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