Cleared Special

K003898 - EBI VUECATH SPINAL ENDOSCOPIC SYSTEM

K003898 is the FDA 510(k) clearance for EBI VUECATH SPINAL ENDOSCOPIC SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Special 510(k) pathway after a 17-day FDA review.

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
Combination Product No
PCCP Authorized No
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 379
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K003898.
SHAVER ABLATOR
K002088 · Linvatec Corp. · Mar 2001
DYONICS CONTROL RF SYSTEM
K003572 · Smith & Nephew, Inc. · Feb 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · Ebi, L.P. · Feb 2001
METRX SYSTEM
K002931 · Medtronic Sofamor Danek, Inc. · Nov 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · Radionics, Inc. · Oct 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · Endius, Inc. · Oct 2000