Cleared Traditional

K950347 - LEVEEN NEEDLE ELECTRODE(TM)

K950347 is an FDA 510(k) clearance for LEVEEN NEEDLE ELECTRODE(TM), manufactured by Radiotherapeutics Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K950347 · Radiotherapeutics Corp. · General & Plastic Surgery device
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Feb 1995
Decision
27d
Days
Class 2
Risk

K950347 is an FDA 510(k) clearance for the LEVEEN NEEDLE ELECTRODE(TM). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Radiotherapeutics Corp. (Mountain View, US). The FDA issued a Cleared decision on February 23, 1995 after a review of 27 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 Radiotherapeutics Corp. devices

FDA 510(k) Submission Details - K950347

510(k) Number K950347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date February 23, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 1473
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K950347.
KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE
K950953 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
REUSABLE MONOPOLAR FORCEPS
K950877 · Boston Surgical Products, Inc. · Mar 1995
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
K950507 · American Hydro-Surgical Instruments, Inc. · Mar 1995
NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS
K945694 · American Hydro-Surgical Instruments, Inc. · Feb 1995
VALLEYLAB COATED ELECTRODES
K950188 · Valleylab, Inc. · Feb 1995
NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES
K945317 · American Hydro-Surgical Instruments, Inc. · Feb 1995