Cleared Special

EBI VUECATH SPINAL ENDOSCOPIC SYSTEM (K003898) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003898 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
17d
Days
Class 2
Risk

K003898 is an FDA 510(k) clearance for the EBI VUECATH SPINAL ENDOSCOPIC SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on January 4, 2001 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ebi, L.P. devices

Submission Details

510(k) Number K003898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2000
Decision Date January 04, 2001
Days to Decision 17 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 158
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K003898.
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc. · Jun 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · Aesculap, Inc. · Apr 2001
DYONICS CONTROL RF SYSTEM
K003572 · Smith & Nephew, Inc. · Feb 2001
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · KARL STORZ Endoscopy-America, Inc. · Sep 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · United States Surgical, A Division of Tyco Healthc · Aug 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · Smith & Nephew, Inc. · Jun 2000