Cleared Traditional

K874829 - MEDCO MEMORY RETRACTOR SYSTEM

K874829 is an FDA 510(k) clearance for MEDCO MEMORY RETRACTOR SYSTEM, manufactured by Medical Equipment Development Co., Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K874829 · Medical Equipment Development Co., Inc. · Neurology device
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Mar 1988
Decision
121d
Days
Class 2
Risk

K874829 is an FDA 510(k) clearance for the MEDCO MEMORY RETRACTOR SYSTEM. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Medical Equipment Development Co., Inc. (Cinnaminson, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 121 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 Medical Equipment Development Co., Inc. devices

FDA 510(k) Submission Details - K874829

510(k) Number K874829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1987
Decision Date March 24, 1988
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
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 K874829.
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K892543 · Zinnanti Surgical Instruments, Inc. · May 1989
CRANK FRAME RETRACTOR
K882071 · Karlin Technology, Inc. · Jun 1988
CRANK FRAME RETRACTOR
K881160 · T. Korossurgical Instruments Corp. · Apr 1988
CEDAR(TM) RETRACTOR RING
K873691 · Cedar Surgical, Inc. · Sep 1987
BUDDE-HALO RETRACTOR
K830332 · Ohio Medical Instrument Co., Inc. · Mar 1983
CYCLOPAC TENS
K801855 · Dow Corning Wright · Aug 1980