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Navigated Instruments

by Tyber Medical, LLC

510(k) K252742

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252742↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK252742 Date28 Oct 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Navigated Instruments are sterile, single-use surgical instruments designed for neurosurgical procedures, enabling precise navigation and access during brain surgery. These instruments are intended to assist in minimally invasive techniques, reducing trauma and improving surgical accuracy by aligning with preoperative imaging and real-time tracking systems.

Supplied in sterile packaging, these instruments are intended for single-use only and must be handled with aseptic techniques. They are compatible with MRI environments and are available in various sizes and configurations as specified in the product documentation. Authorized under FDA 510K clearance (K252742) and MDR compliance, they are distributed by Tyber Medical, LLC, Bethlehem, PA.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Are these instruments reusable or designed for single-use only, and how should they be handled during surgery?

    The Navigated Instruments are sterile and intended for single-use only. They must be handled with aseptic techniques to maintain sterility, as they come pre-packaged and are not meant to be reused. This design ensures patient safety and reduces the risk of infection or cross-contamination.

  • Can these instruments be used in an MRI environment, and what types of neurosurgical procedures are they best suited for?

    Yes, the Navigated Instruments are compatible with MRI environments, making them suitable for procedures requiring real-time imaging guidance. They are specifically designed for neurosurgical applications, particularly to assist in minimally invasive techniques—such as brain surgery—by aligning with preoperative imaging and navigation systems to improve precision and reduce trauma.

  • What sizes or configurations are available for these instruments, and how are they packaged?

    The Navigated Instruments come in various sizes and configurations, as detailed in the product documentation. They are supplied in sterile packaging, ensuring readiness for immediate use in the operating room without additional sterilization steps. The packaging maintains sterility until the first use.

  • How are these instruments distributed, and who should buyers contact for inquiries?

    The Navigated Instruments are distributed by Tyber Medical, LLC, based in Bethlehem, PA. For inquiries, buyers or clinicians can contact Chelsea Smith at the manufacturer’s address: *83 S. Commerce Way, Suite 310, Bethlehem, PA 18017*.