Cleared Traditional

K870028 - SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE

K870028 is an FDA 510(k) clearance for SMK SLUYTER-MEHTA CANNULAE, manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K870028 · Radionics, Inc. · Neurology device
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Oct 1987
Decision
294d
Days
Class 2
Risk

K870028 is an FDA 510(k) clearance for the SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on October 26, 1987 after a review of 294 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K870028

510(k) Number K870028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1987
Decision Date October 26, 1987
Days to Decision 294 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 148d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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 Neurology devices follow this clearance model.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 58
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K870028.
DISPOSABLE WET FIELD ERASER
K880925 · Advanced Surgical Products, Inc. · Apr 1988
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
K880951 · Advanced Surgical Products, Inc. · Apr 1988
THE STORZ BIPOLAR PENCIL AND CORD
K880293 · Storz Instrument Co. · Mar 1988
VAXIOM FAMILY OF RF LESION PROBES & ELEC
K802243 · Progress Mankind Technology · Nov 1980