Cleared Traditional

K892215 - UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR...

K892215 is the FDA 510(k) clearance for UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR... by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K892215 · Codman & Shurtleff, Inc. · Neurology device
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Aug 1989
Decision
140d
Days
Class 2
Risk

K892215 is an FDA 510(k) clearance for the UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K892215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date August 21, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 148d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 117
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K892215.
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp. · Dec 1990
ACCU-FLO* UNITIZED SHUNT
K904120 · Codman & Shurtleff, Inc. · Oct 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · Codman & Shurtleff, Inc. · Jul 1990
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 1989
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513 · Cordis Corp. · Aug 1986