Cleared Traditional

K861495 - ELECTROSURGICAL BLADE ELECTRODE (SOLID ...

K861495 is the FDA 510(k) clearance for ELECTROSURGICAL BLADE ELECTRODE (SOLID ... by National Wire & Stamping, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K861495 · National Wire & Stamping, Inc. · General & Plastic Surgery device
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Jun 1986
Decision
58d
Days
Class 2
Risk

K861495 is an FDA 510(k) clearance for the ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by National Wire & Stamping, Inc. (Englewood, US). The FDA issued a Cleared decision on June 19, 1986 after a review of 58 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 National Wire & Stamping, Inc. devices

Submission Details

510(k) Number K861495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date June 19, 1986
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K861495.
MICROBIPOLATOR
K863414 · Treace Medical, Inc. · Sep 1986
NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE
K863360 · Richards Medical Co., Inc. · Sep 1986
ELECTRO-SURGICAL PENCILS
K861742 · Stryker Corp. · Jul 1986
MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS
K861112 · Valleylab, Inc. · May 1986
ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)
K861139 · Conmedcorp · May 1986
PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD
K855084 · Conmedcorp · May 1986