Skip to content

TYRX Neuro Antibacterial Envelope

by Tyrx, Inc. 510(k)

Active United States

510(k) K152678

Overview

The TYRX Neuro Antibacterial Envelope is a polymeric surgical mesh device designed to hold implantable neurostimulators such as vagus nerve stimulators or spinal cord neuromodulators securely in place. It is intended to create a stable environment for the implanted device within the body.

The device is supplied sterile and is intended for single-use. It contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model. The device received FDA 510(k) clearance under K152678 and is classified as a Class II medical device.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152678 Date17 Nov 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Tyrx, Inc.

Questions

  • What is the TYRX Neuro Antibacterial Envelope used for?

    The TYRX Neuro Antibacterial Envelope is a polymeric surgical mesh device designed to hold implantable neurostimulators such as vagus nerve stimulators or spinal cord neuromodulators securely in place, creating a stable environment for the implanted device within the body.

  • Is the TYRX Neuro Antibacterial Envelope sterile and single-use?

    Yes, the device is supplied sterile and is intended for single-use only, as indicated in the device description, to ensure infection control and proper clinical use.

  • What antimicrobial agents does the TYRX Neuro Antibacterial Envelope contain?

    The device contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model, as stated in the device description.

  • What is the FDA clearance number for the TYRX Neuro Antibacterial Envelope?

    The device received FDA 510(k) clearance under K152678, as specified in the device data under the k_number field.

  • What is the device classification of the TYRX Neuro Antibacterial Envelope?

    The TYRX Neuro Antibacterial Envelope is classified as a Class II medical device, as explicitly stated in the device description.