Cleared Traditional

K061297 - ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM

K061297 is an FDA 510(k) clearance for ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM, manufactured by The Anspach Effort, Inc.. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K061297 · The Anspach Effort, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
262d
Days
Class 2
Risk

K061297 is an FDA 510(k) clearance for the ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 262 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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 The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K061297

510(k) Number K061297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2006
Decision Date January 26, 2007
Days to Decision 262 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
114d slower than avg
Panel avg: 148d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 - HBB Motor, Drill, Pneumatic

All 22
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