Cleared Traditional

K913594 - DYNEX IIIB, MODEL 89002026

K913594 is an FDA 510(k) clearance for DYNEX IIIB, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K913594 · Medtronic Vascular · Neurology device
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Aug 1991
Decision
10d
Days
Class 2
Risk

K913594 is an FDA 510(k) clearance for the DYNEX IIIB, MODEL 89002026. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 23, 1991 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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.

FDA 510(k) Submission Details - K913594

510(k) Number K913594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date August 23, 1991
Days to Decision 10 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 149d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K913594.
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SOLITENS MODIFIED
K913522 · Innovative Designer Products, Inc. · Aug 1991
GLOBAL CARE MICRO II
K910244 · Globalcare Intl., Inc. · Jul 1991
SX90 (TM),MODEL 4800S
K912348 · Medical Devices, Inc. · Jun 1991
AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
K905526 · Agar Ginosar Electronics · Jun 1991
K913594 · DYNEX IIIB, MODEL 89002026
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