Cleared Traditional

K960714 - ISG VIEWING WAND

K960714 is an FDA 510(k) clearance for ISG VIEWING WAND, manufactured by I.S.G. Technologies, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K960714 · I.S.G. Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
98d
Days
Class 2
Risk

K960714 is an FDA 510(k) clearance for the ISG VIEWING WAND. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on May 29, 1996 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all I.S.G. Technologies, Inc. devices

FDA 510(k) Submission Details - K960714

510(k) Number K960714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date May 29, 1996
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
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 278
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K960714.
BRAINLAB HEADPINS
K954789 · Brainlab AG · Aug 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961858 · Radionics, Inc. · Aug 1996
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
K961639 · Elekta Instrument AB · Jul 1996
MAYFIELD-ACCISS WORKSTATION
K955397 · Nomos Corp. · Apr 1996
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · Codman & Shurtleff, Inc. · Feb 1996
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996