Cleared Traditional

K961903 - MAGELLAN

K961903 is an FDA 510(k) clearance for MAGELLAN, manufactured by Biosense, Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 830-day FDA review.

K961903 · Biosense, Ltd. · Neurology device
Download Printable Device Report (PDF)
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Aug 1998
Decision
830d
Days
Class 2
Risk

K961903 is an FDA 510(k) clearance for the MAGELLAN. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Biosense, Ltd. (Tirat Hacarmel, IL). The FDA issued a Cleared decision on August 24, 1998 after a review of 830 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Biosense, Ltd. devices

FDA 510(k) Submission Details - K961903

510(k) Number K961903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date August 24, 1998
Days to Decision 830 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
682d slower than avg
Panel avg: 148d · This submission: 830d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 333
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