Cleared Traditional

K003403 - ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999

K003403 is an FDA 510(k) clearance for ENDOSCOPIC MONOPOLAREECTRODE, manufactured by Highland / Marietta, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K003403 · Highland / Marietta, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
187d
Days
Class 2
Risk

K003403 is an FDA 510(k) clearance for the ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Highland / Marietta, Inc. (Mentor, US). The FDA issued a Cleared decision on May 7, 2001 after a review of 187 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Highland / Marietta, Inc. devices

FDA 510(k) Submission Details - K003403

510(k) Number K003403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2000
Decision Date May 07, 2001
Days to Decision 187 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 115d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOS Device Classification - Class 2, Special Controls

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - JOS Electrode, Electrosurgical

All 27
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K003403.
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
K050923 · Conmed Linvatec · May 2005
REPROCESSED ELECTROSURGICAL ELECTRODE
K012684 · Sterilmed, Inc. · Jan 2002
MEDLINE GROUNDING PAD
K011515 · Medline Industries, Inc. · Jul 2001
ULTRABLATOR ELECTRODE
K993885 · Linvatec Corp. · Feb 2000
CAPSULAR SHRINKAGE ELECTRODE
K991830 · Linvatec Corp. · Aug 1999
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · Aaron Medical Industries · Jun 1998