Cleared Traditional

ANSPACH POWERED KERRISON SYSTEM (PKS) (K022907) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022907 · The Anspach Effort, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
48d
Days
Class 2
Risk

K022907 is an FDA 510(k) clearance for the ANSPACH POWERED KERRISON SYSTEM (PKS). Classified as Rongeur, Powered (product code HAD), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on October 21, 2002 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Anspach Effort, Inc. devices

Submission Details

510(k) Number K022907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date October 21, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 148d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.