Cleared Traditional

K102802 - INTEGRA ELECTRODE TUNNELING NEEDLE

K102802 is the FDA 510(k) clearance for INTEGRA ELECTRODE TUNNELING NEEDLE by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code GYC) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K102802 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
57d
Days
Class 2
Risk

K102802 is an FDA 510(k) clearance for the INTEGRA ELECTRODE TUNNELING NEEDLE. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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 Integra LifeSciences Corporation devices

Submission Details

510(k) Number K102802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2010
Decision Date November 23, 2010
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 148d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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 - GYC Electrode, Cortical

All 14
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K102802.
AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH · Mar 2019
SD LTM STIM Cortical Stimulator
K180761 · Micromed S.P.A. · Jun 2018
g.Estim PRO
K173684 · G.Tec Medical Engineering GmbH · May 2018
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc. · Aug 1997
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424 · Radionics, Inc. · Nov 1993
OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc. · Apr 1993