Cleared Traditional

K003405 - ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO

K003405 is an FDA 510(k) clearance for ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, manufactured by Highland / Marietta, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K003405 · Highland / Marietta, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
187d
Days
Class 2
Risk

K003405 is an FDA 510(k) clearance for the ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLAR.... Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), 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 Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Highland / Marietta, Inc. devices

FDA 510(k) Submission Details - K003405

510(k) Number K003405 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 Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 160d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 35
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K003405.
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K103726 · Integra LifeSciences Corporation · Feb 2012
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K070315 · Lina Medical Aps · Oct 2007
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · Aesculap, Inc. · Jun 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · Hdc Corp. · Mar 2001
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K981463 · Omnitech Systems, Inc. · Jul 1998
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K981464 · Omnitech Systems, Inc. · Jul 1998