Cleared Traditional

K924876 - TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED

K924876 is an FDA 510(k) clearance for TENS DEVICE FOR RELIEF OF CHRONIC PAIN, manufactured by Graham-Field, Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 524-day FDA review.

K924876 · Graham-Field, Inc. · Neurology device
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Mar 1994
Decision
524d
Days
Class 2
Risk

K924876 is an FDA 510(k) clearance for the TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Graham-Field, Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 524 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Graham-Field, Inc. devices

FDA 510(k) Submission Details - K924876

510(k) Number K924876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date March 01, 1994
Days to Decision 524 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 148d · This submission: 524d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
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 - GZT Retractor, Self-retaining, For Neurosurgery

All 21
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K924876.
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
K964402 · V. Mueller Neuro/Spine · Jan 1997
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
K960807 · Ohio Medical Instrument Co., Inc. · May 1996
CERVICAL SELF-RETAINING RETRACTOR
K935529 · T. Korossurgical Instruments Corp. · Mar 1994
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233 · Codman & Shurtleff, Inc. · Jul 1991
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K895395 · Baxter Healthcare Corp · Oct 1989
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K892543 · Zinnanti Surgical Instruments, Inc. · May 1989