Cleared Traditional

K905060 - ELECTRODE EXTENDER

K905060 is an FDA 510(k) clearance for ELECTRODE EXTENDER, manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K905060

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.

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 26
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
ELECTROSURGICAL ELECTRODE
K895331 · New England Surgical Instrument Corp. · Sep 1989
MICRO CAUTERY NEEDLES
K891400 · Zinnanti Surgical Instruments, Inc. · Apr 1989