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FDA 510(k)

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)

K-Number: K192636 · 2020-04-08

ApplicantMedtronic, Inc.
Decision Date2020-04-08
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K192636. 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 2020-04-08. The listed applicant is Medtronic, Inc.. The 510(k) number is K192636.

When did TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) receive FDA 510(k) clearance?

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) received FDA 510(k) clearance on 2020-04-08, under 510(k) number K192636.

Who is the listed applicant for TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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