Cleared Traditional

K990788 - AD-TECH'S FORAMEN OVALE ELECTRODE

K990788 is an FDA 510(k) clearance for AD-TECH'S FORAMEN OVALE ELECTRODE, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K990788 · Ad-Tech Medical Instrument Corp · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
237d
Days
Class 2
Risk

K990788 is an FDA 510(k) clearance for the AD-TECH'S FORAMEN OVALE ELECTRODE. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on November 2, 1999 after a review of 237 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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.

FDA 510(k) Submission Details - K990788

510(k) Number K990788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date November 02, 1999
Days to Decision 237 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
88d slower than avg
Panel avg: 149d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 55
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K990788.
RECORDING AND STIMULATING ELECTRODE
K012850 · Radionics, A Division of Tyco Healthcare Group LP · Nov 2001
MICROTARGETING ELECTRODE
K991522 · FHC, Inc. · Aug 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622 · Alpha Omega , Ltd. · Jan 2000
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
K991077 · Microrecording Systems Consultants, LLC · Jun 1999
NEUROMAP
K981820 · Radionics, Inc. · Nov 1998
PALI-TRODE
K981015 · Preferred Instruments · Jun 1998