Cleared Traditional

K041978 - REPROCESSED DIAMOND BURS

K041978 is an FDA 510(k) clearance for REPROCESSED DIAMOND BURS, manufactured by Alliance Medical Corp.. The device is a Class 2 Neurology device with product code NLN cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K041978 · Alliance Medical Corp. · Neurology device
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Nov 2004
Decision
123d
Days
Class 2
Risk

K041978 is an FDA 510(k) clearance for the REPROCESSED DIAMOND BURS. Classified as Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed (product code NLN), Class II - Special Controls.

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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 Alliance Medical Corp. devices

FDA 510(k) Submission Details - K041978

510(k) Number K041978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date November 23, 2004
Days to Decision 123 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
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLN Device Classification - Class 2, Special Controls

Product Code NLN Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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.