Cleared Traditional

K902517 - NEUROSURGICAL HEADFRAME ACCESSORIES

K902517 is an FDA 510(k) clearance for NEUROSURGICAL HEADFRAME ACCESSORIES, manufactured by Sims Surgical, Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K902517 · Sims Surgical, Inc. · Neurology device
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Jul 1990
Decision
26d
Days
Class 2
Risk

K902517 is an FDA 510(k) clearance for the NEUROSURGICAL HEADFRAME ACCESSORIES. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Sims Surgical, Inc. (Keene, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 26 days - a notably fast clearance cycle.

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: 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 Sims Surgical, Inc. devices

FDA 510(k) Submission Details - K902517

510(k) Number K902517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1990
Decision Date July 03, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
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 32
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K902517.
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
CRANK FRAME RETRACTOR
K882071 · Karlin Technology, Inc. · Jun 1988