Cleared Traditional

K860479 - GREEN-LINE BIPOLAR COAGULATION UNIT

K860479 is the FDA 510(k) clearance for GREEN-LINE BIPOLAR COAGULATION UNIT by Grieshaber & Co.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K860479 · Grieshaber & Co. · General & Plastic Surgery device
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May 1986
Decision
83d
Days
Class 2
Risk

K860479 is an FDA 510(k) clearance for the GREEN-LINE BIPOLAR COAGULATION UNIT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Grieshaber & Co. (Fallisington, US). The FDA issued a Cleared decision on May 1, 1986 after a review of 83 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 Grieshaber & Co. devices

Submission Details

510(k) Number K860479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1986
Decision Date May 01, 1986
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1141
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K860479.
ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)
K861139 · Conmedcorp · May 1986
PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD
K855084 · Conmedcorp · May 1986
E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
K861036 · Valleylab, Inc. · May 1986
NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270
K851304 · Richards Medical Co., Inc. · Sep 1985
NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,
K851305 · Richards Medical Co., Inc. · Sep 1985
SINGLE USE ARTHROSCOPY ELECTRODE
K852355 · Aspen Laboratories, Inc. · Sep 1985