Cleared Traditional

K882802 - STORZ DISPOSABLE BIPOLAR PENCILS

K882802 is the FDA 510(k) clearance for STORZ DISPOSABLE BIPOLAR PENCILS by Storz Instrument Co.. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K882802 · Storz Instrument Co. · Neurology device
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Aug 1988
Decision
41d
Days
Class 2
Risk

K882802 is an FDA 510(k) clearance for the STORZ DISPOSABLE BIPOLAR PENCILS. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on August 17, 1988 after a review of 41 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 Storz Instrument Co. devices

Submission Details

510(k) Number K882802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1988
Decision Date August 17, 1988
Days to Decision 41 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
107d faster than avg
Panel avg: 148d · This submission: 41d
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 37
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K882802.
BMC RF CANNULA
K972846 · Baylis Medical Co., Inc. · Jul 1998
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
K980430 · Radionics, Inc. · Mar 1998
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K884347 · Advanced Surgical Products, Inc. · Dec 1988
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