Cleared Traditional

K961113 - CNS INTERCHANGEABLE BIT CRANIAL DRILL

K961113 is an FDA 510(k) clearance for CNS INTERCHANGEABLE BIT CRANIAL DRILL, manufactured by Clinical Neuro Systems, LLC. The device is a Class 2 Neurology device with product code HBG cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961113 · Clinical Neuro Systems, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
77d
Days
Class 2
Risk

K961113 is an FDA 510(k) clearance for the CNS INTERCHANGEABLE BIT CRANIAL DRILL. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Clinical Neuro Systems, LLC (Exton, US). The FDA issued a Cleared decision on June 5, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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 Clinical Neuro Systems, LLC devices

FDA 510(k) Submission Details - K961113

510(k) Number K961113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1996
Decision Date June 05, 1996
Days to Decision 77 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
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBG Device Classification - Class 2, Special Controls

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
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 - HBG Drills, Burrs, Trephines & Accessories (manual)

All 11
Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K961113.
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · Mri Interventions, Inc. · Jul 2015
MRII CRAINIAL DRILL
K122456 · Mri Interventions, Inc. · Mar 2013
FRAMELOCK
K022370 · Medtronic Xomed, Inc. · Oct 2002
PS MEDICAL VENTRICULOSTOMY KIT
K915546 · Pudenz-Schulte Medical Research Corp. · Dec 1991
PS MEDICAL CRANIAL HAND DRILL
K904283 · Pudenz-Schulte Medical Research Corp. · Oct 1990
NEUROSURGICAL DRILLS: STILLE, HUDSON
K892531 · Zinnanti Surgical Instruments, Inc. · May 1989