Cleared Traditional

K961858 - COSGROVE DEPTH ELECTRODE KIT(CDEK)

K961858 is an FDA 510(k) clearance for COSGROVE DEPTH ELECTRODE KIT(CDEK), manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K961858 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
85d
Days
Class 2
Risk

K961858 is an FDA 510(k) clearance for the COSGROVE DEPTH ELECTRODE KIT(CDEK). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Radionics, Inc. devices

FDA 510(k) Submission Details - K961858

510(k) Number K961858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date August 07, 1996
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 352
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K961858.
STEALTHSTATION SYSTEM
K963173 · Surgical Navigation Technologies, Inc. · Oct 1996
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
K961844 · Radionics Software Applications, Inc. · Oct 1996
BRAINLAB HEADPINS
K954789 · Brainlab AG · Aug 1996
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
K961639 · Elekta Instrument AB · Jul 1996
ISG VIEWING WAND
K960714 · I.S.G. Technologies, Inc. · May 1996
MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
K961120 · Howmedica Leibinger, Inc. · May 1996