Cleared Traditional

K963577 - RADIONICS SLUIJTER-MEHTA CANNULA

K963577 is an FDA 510(k) clearance for RADIONICS SLUIJTER-MEHTA CANNULA, manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K963577 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
76d
Days
Class 2
Risk

K963577 is an FDA 510(k) clearance for the RADIONICS SLUIJTER-MEHTA CANNULA. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - 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 - K963577

510(k) Number K963577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1996
Decision Date November 21, 1996
Days to Decision 76 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
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 - GXD Generator, Lesion, Radiofrequency

All 30
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K963577.
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
K983214 · Rita Medical Systems · Mar 2000
RFG-3C PLUS
K982489 · Radionics, Inc. · Oct 1998
RFG-3CF
K965182 · Radionics, Inc. · Mar 1997
LEKSELL NEURO GENERATOR AND ACCESSORIES
K941823 · Elekta Instruments, Inc. · Mar 1996
MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
K922064 · Cardiotronics, Inc. · Dec 1992
MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR
K901540 · Radionics, Inc. · Apr 1991