Cleared Traditional

K062413 - AESCULAP PNEUMATIC KERRISON

K062413 is an FDA 510(k) clearance for AESCULAP PNEUMATIC KERRISON, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HAD cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K062413 · Aesculap, Inc. · Neurology device
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Nov 2006
Decision
96d
Days
Class 2
Risk

K062413 is an FDA 510(k) clearance for the AESCULAP PNEUMATIC KERRISON. Classified as Rongeur, Powered (product code HAD), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 21, 2006 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4845 - 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

FDA 510(k) Submission Details - K062413

510(k) Number K062413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2006
Decision Date November 21, 2006
Days to Decision 96 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
52d faster than avg
Panel avg: 148d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAD Device Classification - Class 2, Special Controls

Product Code HAD Rongeur, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4845
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.