Cleared Traditional

K935529 - CERVICAL SELF-RETAINING RETRACTOR

K935529 is an FDA 510(k) clearance for CERVICAL SELF-RETAINING RETRACTOR, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K935529 · T. Korossurgical Instruments Corp. · Neurology device
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Mar 1994
Decision
126d
Days
Class 2
Risk

K935529 is an FDA 510(k) clearance for the CERVICAL SELF-RETAINING RETRACTOR. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 126 days - within the typical 510(k) review window.

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: 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 T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K935529

510(k) Number K935529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date March 22, 1994
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
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 13
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K935529.
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
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HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · Spinal Concepts, Inc. · Apr 2005
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