Drills, Burrs, Trephines & Accessories (Manual)
Drills, Burrs, Trephines and Accessories (Manual) are hand-operated neurosurgical cutting tools used to manually perforate or remove skull bone during cranial procedures, providing tactile feedback and control without reliance on a power source. They are classified as Class 2 devices (moderate risk), requiring 510(k) premarket notification. The product code is HBG under regulation 21 CFR 882.4300 in the Neurology specialty. These devices are eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HBG
- Device Class
- FDA class 2
- Regulation Number
- 882.4300
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252696 | LEGACY | Nov 21, 2025 | Substantially Equivalent | Phasor Health, LLC |
| K153587 | Taps for Resorbable Screws | Jan 18, 2017 | Substantially Equivalent | Synthes (USA) Products, LLC |
| K162884 | SpineGuard DSG Zavation Screw System | Jan 12, 2017 | Substantially Equivalent | Spineguard S.A. |
| K160129 | MRII Cranial Drill and Accessories | Mar 26, 2016 | Substantially Equivalent | Mri Interventions, Inc. |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Jul 08, 2015 | Substantially Equivalent | Mri Interventions, Inc. |
| K122456 | MRII CRAINIAL DRILL | Mar 22, 2013 | Substantially Equivalent | Mri Interventions, Inc. |
| K022712 | HAND DRILL, MODEL 11-9901-7 | Nov 12, 2002 | Substantially Equivalent | Medical Design, LLC |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Oct 18, 2002 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Jun 05, 1996 | Substantially Equivalent | Clinical Neuro Systems, LLC |
| K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Aug 05, 1993 | Substantially Equivalent | Neurodynamics, Inc. |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Dec 30, 1991 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Oct 03, 1990 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Sep 20, 1990 | Substantially Equivalent | Ruggles Corp. |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | May 05, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K875018 | GHAJAR GUIDE TWIST DRILL | Jan 28, 1988 | Substantially Equivalent | Neurodynamics, Inc. |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Dec 30, 1987 | Substantially Equivalent | Solway, Inc. |
| K862160 | CAMINO HAND DRILL - MODEL 030 | Jul 18, 1986 | Substantially Equivalent | Camino Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.