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EBI VueCath Spinal Endoscopic System

by Ebi, L.P. 510(k)

Active United States

510(k) K010179

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK010179 Date9 Feb 2001ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1006-03 FDA Unclassified (pre-2012) initiated 17 Jun 2003 on shared 510(k) K010179

    Non sterile device is labeled sterile.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
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 EBI VueCath Spinal Endoscopic System is an arthroscope designed for visualization of the lumbar and sacral epidural spaces. It falls under the classification of an arthroscope, a device used primarily in orthopedic procedures to aid in spinal diagnostics and minimally invasive interventions.

This system comprises a fiberscope, disposable catheter, and associated accessories, including a camera coupler and light cord adaptors. It is intended for use in clinical settings by physicians to assist in diagnosing spinal diseases and is supplied as a reusable system with single-use disposable components. The device holds FDA 510(k) clearance under product code HRX, with a decision date of January 4, 2001.

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