Cleared Traditional

K905060 - ELECTRODE EXTENDER

K905060 is the FDA 510(k) clearance for ELECTRODE EXTENDER by Megadyne Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code JOS) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K905060 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Apr 1991
Decision
155d
Days
Class 2
Risk

K905060 is an FDA 510(k) clearance for the ELECTRODE EXTENDER. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Murray, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 155 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 Megadyne Medical Products, Inc. devices

Submission Details

510(k) Number K905060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date April 12, 1991
Days to Decision 155 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K905060.
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950455 · Aaron Medical Industries · May 1995
ELECTRODES
K944992 · Linvatec Corp. · Apr 1995
MILES SODIUM METHOD
K923037 · Heraeus Kulzer, Inc. · Sep 1992
ELECTRODE, ELECTROSURGERY
K903302 · Megadyne Medical Products, Inc. · Oct 1990
MICRO CAUTERY NEEDLES
K891400 · Zinnanti Surgical Instruments, Inc. · Apr 1989
YESNG PATIENT PLATE #80226
K881144 · Ferguson Medical · Apr 1988