Cleared Traditional

K972332 - AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM

K972332 is the FDA 510(k) clearance for AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM by Aesculap, Inc.. It is a Class 2 Neurology device (product code GXN) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K972332 · Aesculap, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 1998
Decision
207d
Days
Class 2
Risk

K972332 is an FDA 510(k) clearance for the AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 207 days - an extended review cycle.

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: 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 Aesculap, Inc. devices

Submission Details

510(k) Number K972332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date January 16, 1998
Days to Decision 207 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
59d slower than avg
Panel avg: 148d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.