Cleared Traditional

K880951 - DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150

K880951 is the FDA 510(k) clearance for DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 by Advanced Surgical Products, Inc.. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K880951 · Advanced Surgical Products, Inc. · Neurology device
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Apr 1988
Decision
37d
Days
Class 2
Risk

K880951 is an FDA 510(k) clearance for the DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 37 days - a notably fast clearance 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: 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 Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K880951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date April 13, 1988
Days to Decision 37 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
111d faster than avg
Panel avg: 148d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K880951.
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K884347 · Advanced Surgical Products, Inc. · Dec 1988
STORZ DISPOSABLE BIPOLAR PENCILS
K882802 · Storz Instrument Co. · Aug 1988
DISPOSABLE WET FIELD ERASER
K880925 · Advanced Surgical Products, Inc. · Apr 1988
THE STORZ BIPOLAR PENCIL AND CORD
K880293 · Storz Instrument Co. · Mar 1988
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
K870028 · Radionics, Inc. · Oct 1987