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Nedbond Ejector Kerrison Rongeur

by Redmond Neurotechnologies Corp.

510(k) K933978

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 NumberK933978 Date12 Jan 1994ClearedStatusActive

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  • Withdrawn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
HAE
Device Class
Class II
Regulation
21 CFR Part 882.4840
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 Nedbond Ejector Kerrison Rongeur is a manual surgical instrument classified as a Rongeur (OpenFDA: HAE). Designed for neurosurgical procedures, it is used to remove bone, tissue, or foreign material during spinal or cranial operations. Its Kerrison design enables precise cutting and shaping of bony structures, particularly in spinal decompression surgeries.

Supplied as a reusable device, the Nedbond Ejector Kerrison Rongeur is intended for use in sterile operating room environments. It is regulated under FDA 510(k) clearance (K933978) and falls under the Neurology specialty classification (OpenFDA: medical_specialty_description). The device adheres to regulatory standards outlined in 21 CFR 882.4840, ensuring compliance for surgical applications. No MRI safety or single-use specifications are noted in the available data.

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 Nedbond Ejector Kerrison Rongeur used for?

    The Nedbond Ejector Kerrison Rongeur is specifically designed for neurosurgical procedures to remove bone, tissue, or foreign material during spinal or cranial operations. Its Kerrison design allows for precise cutting and shaping of bony structures, making it particularly useful in spinal decompression surgeries where accuracy is critical.

  • Is the Nedbond Ejector Kerrison Rongeur single-use or reusable?

    The Nedbond Ejector Kerrison Rongeur is supplied as a reusable device. It is intended for use in sterile operating room environments, where it can be cleaned, sterilized, and reused for subsequent procedures. This design aligns with standard practices for surgical instruments requiring high durability and precision.

  • What regulatory approval does the Nedbond Ejector Kerrison Rongeur hold?

    The device holds FDA 510(k) clearance under the classification K933978, with a decision date of January 12, 1994. It adheres to regulatory standards outlined in 21 CFR 882.4840, ensuring compliance for surgical applications in neurosurgery. The clearance confirms it is substantially equivalent to a legally marketed predicate device.

  • Does the Nedbond Ejector Kerrison Rongeur have any MRI safety considerations?

    The available data does not specify any MRI safety features or restrictions for the Nedbond Ejector Kerrison Rongeur. Clinicians should verify compatibility with their MRI systems and protocols before use in MRI environments, as standard surgical steel instruments may pose risks in magnetic fields.

  • What specialty classification does this device fall under?

    The Nedbond Ejector Kerrison Rongeur is classified under the Neurology specialty in the OpenFDA database. This classification reflects its primary use in neurosurgical procedures, particularly for spinal and cranial applications where bone removal or reshaping is required.