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Ultra-Line Rongeur

by V. Mueller Neuro/Spine 510(k)

Active United States

510(k) K943635

Overview

The Ultra-Line Rongeur is a manual surgical instrument used for bone and tissue removal in neurosurgical and spinal procedures. It is designed for precise dissection in tight anatomical spaces where controlled removal of small amounts of bone or intervertebral disc material is required.

The device is supplied in various sizes and configurations, including straight and angled models with different shaft lengths. It is a Class II medical device that received FDA 510(k) clearance in 1994 with product code HAE. The instrument is intended for single-use or reusable applications depending on the specific model and sterilization protocol.

AI-generated from registry data, 28 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 NumberK943635 Date7 Dec 1994ClearedStatusActive

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
HAE
Device Class
Class II
Regulation
21 CFR Part 882.4840
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Ultra-Line Rongeur used for?

    The Ultra-Line Rongeur is a manual surgical instrument designed for precise dissection in tight anatomical spaces where controlled removal of small amounts of bone or intervertebral disc material is required in neurosurgical and spinal procedures.

  • How is the Ultra-Line Rongeur supplied?

    The device is supplied in various sizes and configurations, including straight and angled models with different shaft lengths, to accommodate different surgical needs and anatomical access requirements.

  • Is the Ultra-Line Rongeur single-use or reusable?

    The instrument is intended for either single-use or reusable applications depending on the specific model and the sterilization protocol followed, as determined by the manufacturer's instructions.

  • What is the regulatory status of the Ultra-Line Rongeur?

    The Ultra-Line Rongeur is a Class II medical device that received FDA 510(k) clearance in 1994 with product code HAE, meaning it has been determined to be substantially equivalent to existing devices.