Cleared Traditional

K971799 - PRECISION FLOW OSV II

K971799 is an FDA 510(k) clearance for PRECISION FLOW OSV II, manufactured by Elekta Implants, SA. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K971799 · Elekta Implants, SA · Neurology device
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Feb 1998
Decision
267d
Days
Class 2
Risk

K971799 is an FDA 510(k) clearance for the PRECISION FLOW OSV II. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Elekta Implants, SA (Coral Gables, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 267 days - an extended review cycle.

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 Elekta Implants, SA devices

FDA 510(k) Submission Details - K971799

510(k) Number K971799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date February 06, 1998
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 148d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K971799.
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
K981046 · Medtronic PS Medical · Jun 1998
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
K974726 · Elekta Implants, SA · Mar 1998
GEMINI STANDARD AND MINI VALVES
K974708 · Neurocare Group · Mar 1998
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · Johnson & Johnson Professionals, Inc. · Dec 1997
MAURICE WORLDWIDE SHUNT SYSTEM
K973525 · Integra Neurocare, LLC · Dec 1997
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
K972994 · Integra Neurocare, LLC · Nov 1997