Cleared Traditional

K896156 - COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM

K896156 is an FDA 510(k) clearance for COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM, manufactured by Stereotactic Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K896156 · Stereotactic Medical Systems, Inc. · Neurology device
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Dec 1989
Decision
43d
Days
Class 2
Risk

K896156 is an FDA 510(k) clearance for the COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Stereotactic Medical Systems, Inc. (New Harford, US). The FDA issued a Cleared decision on December 6, 1989 after a review of 43 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 Stereotactic Medical Systems, Inc. devices

FDA 510(k) Submission Details - K896156

510(k) Number K896156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date December 06, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
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 14
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K896156.
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · Spinal Concepts, Inc. · Apr 2005
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
K881160 · T. Korossurgical Instruments Corp. · Apr 1988