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Endius Spine Endoscope

by Endius, Inc.

510(k) K982819

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 NumberK982819 Date27 Jan 1999ClearedStatusActive

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  • Withdrawn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
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
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 Endius Spine Endoscope is a neurological endoscope designed for spinal procedures. It is a rigid, percutaneous instrument used to visualize and assist in the removal of herniated disc material within the lumbar spine, enabling direct inspection of spinal anatomy during minimally invasive surgery.

This device is intended for single-use and is supplied sterile, intended for percutaneous lumbar spine applications. It is classified as a Class II medical device under FDA regulation 882.1480 and holds a 510(k) clearance (K982819) for substantial equivalence in neurology. No additional MRI safety or reusable specifications are noted in the regulatory data.

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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 Endius Spine Endoscope used for?

    The Endius Spine Endoscope is a rigid, percutaneous neurological endoscope designed specifically for spinal procedures. It enables direct visualization of spinal anatomy and assists in the removal of herniated disc material within the lumbar spine during minimally invasive surgery. Its primary purpose is to enhance precision and reduce invasiveness in these procedures.

  • How is the Endius Spine Endoscope supplied?

    The Endius Spine Endoscope is supplied sterile and intended for single-use only. This ensures safety and reduces the risk of cross-contamination between patients, aligning with best practices for minimally invasive surgical instruments.

  • Is the Endius Spine Endoscope reusable?

    No, the Endius Spine Endoscope is explicitly designed for single-use. Single-use devices are engineered to maintain sterility and performance for one procedure, eliminating the need for cleaning, sterilization, and potential degradation over repeated use.

  • What are the key specifications or distinguishing features of this endoscope?

    The Endius Spine Endoscope is classified as a Class II medical device under FDA regulation 882.1480. It holds a 510(k) clearance (K982819) for substantial equivalence in neurology, indicating it meets FDA standards for safety and effectiveness in its intended use. The device is rigid and percutaneous, tailored for lumbar spine applications.

  • How should the Endius Spine Endoscope be stored?

    Since the Endius Spine Endoscope is supplied sterile and intended for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains uncontaminated and ready for use when needed.