Cleared Abbreviated

ELRAN 01 SYSTEM (K002431) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K002431 · Envision Advanced Medical System, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
77d
Days
Class 2
Risk

K002431 is an FDA 510(k) clearance for the ELRAN 01 SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Envision Advanced Medical System, Ltd. (Washington, US). The FDA issued a Cleared decision on October 24, 2000 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Envision Advanced Medical System, Ltd. devices

Submission Details

510(k) Number K002431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2000
Decision Date October 24, 2000
Days to Decision 77 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 356
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K002431.
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · KARL STORZ Endoscopy-America, Inc. · May 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · Smith & Nephew, Inc. · Apr 2001
3D ENDOSCOPE
K002924 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · Intuitive Surgical, Inc. · Aug 2000
KSEA MANHES PNEUMOTROCAR
K000769 · KARL STORZ Endoscopy-America, Inc. · Jun 2000
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · Smith & Nephew, Inc. · Apr 1999