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Lyoplant Onlay

by Aesculap, Inc.

510(k) K122791

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122791 Date4 Jun 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GXQ
Device class
Class II
Regulation
21 CFR Part 882.5910
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lyoplant Onlay is a biological, absorbable dura substitute classified as a dura substitute (OpenFDA: Dura Substitute, Product Code GXQ). It consists of a bilayer membrane designed to replace or extend connective tissue structures in neurosurgical procedures, providing a protective barrier for the brain.

Supplied as a sterile, single-use device, the Lyoplant Onlay is intended for use in neurosurgical settings where dura mater repair or reinforcement is required. It is regulated under FDA 510(k) clearance (K122791) and falls under Class II medical devices. Storage and handling must adhere to sterile surgical protocols to ensure integrity before use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Lyoplant Onlay used for in neurosurgery?

    The Lyoplant Onlay is designed as a biological, absorbable dura substitute to replace or reinforce connective tissue structures during neurosurgical procedures. Its bilayer membrane acts as a protective barrier for the brain, helping to prevent complications such as cerebrospinal fluid leaks or tissue adhesion, particularly in cases where dura mater repair or reinforcement is required.

  • Is the Lyoplant Onlay sterile and single-use?

    Yes, the Lyoplant Onlay is supplied as a sterile, single-use device. Sterility is critical for neurosurgical applications, and adherence to sterile surgical protocols during storage and handling ensures the device remains intact and uncontaminated before use.

  • How is the Lyoplant Onlay regulated and classified?

    The Lyoplant Onlay is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K122791). This classification and clearance indicate it is deemed substantially equivalent to a predicate device already on the market, ensuring it meets established safety and effectiveness standards for dura substitutes in neurosurgery.

  • What storage and handling precautions should be taken with the Lyoplant Onlay?

    The Lyoplant Onlay must be stored and handled according to sterile surgical protocols to maintain its integrity. This includes keeping it in its original packaging until ready for use, protecting it from contamination, and ensuring it is not exposed to extreme temperatures or moisture, which could compromise its sterility or structural properties.

  • Is the Lyoplant Onlay intended for reuse or is it disposable?

    The Lyoplant Onlay is explicitly designed for single-use only. As a sterile, absorbable dura substitute, it is not intended to be reused on multiple patients or even on the same patient after initial use, as reuse could introduce infection risks or compromise its intended function and safety.