Cleared Traditional

K013255 - SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF

K013255 is an FDA 510(k) clearance for SURGITRON 120 IEC (ALSO KNOWN AS SURGIT..., manufactured by Ellman Intl., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K013255 · Ellman Intl., Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2001
Decision
40d
Days
Class 2
Risk

K013255 is an FDA 510(k) clearance for the SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ellman Intl., Inc. (Hewlett, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ellman Intl., Inc. devices

FDA 510(k) Submission Details - K013255

510(k) Number K013255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2001
Decision Date November 07, 2001
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1471
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K013255.
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
K013463 · Arthrocare Corp. · Nov 2001
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · Sterilmed, Inc. · Nov 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
K012700 · Vanguard Medical Concepts, Inc. · Nov 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K012695 · Vanguard Medical Concepts, Inc. · Oct 2001
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
K013348 · Erbe USA, Inc. · Oct 2001
ARTHROCARE ELECTROSURGERY WANDS
K012519 · Arthrocare Corp. · Oct 2001