Cleared Traditional

K971252 - SEVRAIN CRANIAL CLAMP

K971252 is an FDA 510(k) clearance for SEVRAIN CRANIAL CLAMP, manufactured by Ikonos Corp.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 459-day FDA review.

K971252 · Ikonos Corp. · Neurology device
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Jul 1998
Decision
459d
Days
Class 2
Risk

K971252 is an FDA 510(k) clearance for the SEVRAIN CRANIAL CLAMP. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Ikonos Corp. (Portland, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - 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 Ikonos Corp. devices

FDA 510(k) Submission Details - K971252

510(k) Number K971252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1997
Decision Date July 06, 1998
Days to Decision 459 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 148d · This submission: 459d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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.