HBG · Drills, Burrs, Trephines & Accessories (Manual)
Neurology · 21 CFR 882.4300 · Class 2
Overview
| Product Code | HBG |
|---|---|
| Device Name | Drills, Burrs, Trephines & Accessories (Manual) |
| Regulation | 21 CFR 882.4300 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252696 | LEGACY | Phasor Health, LLC | Nov 21, 2025 | SESE |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | Jan 18, 2017 | SESE |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | Jan 12, 2017 | SESE |
| K160129 | MRII Cranial Drill and Accessories | Mri Interventions, Inc. | Mar 26, 2016 | SESE |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | Jul 8, 2015 | SESE |
| K122456 | MRII CRAINIAL DRILL | Mri Interventions, Inc. | Mar 22, 2013 | SESE |
| K022712 | HAND DRILL, MODEL 11-9901-7 | Medical Design, LLC | Nov 12, 2002 | SESE |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | Oct 18, 2002 | SESE |
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Clinical Neuro Systems, LLC | Jun 5, 1996 | SESE |
| K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | Aug 5, 1993 | SESE |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | Dec 30, 1991 | SESE |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | Oct 3, 1990 | SESE |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | Sep 20, 1990 | SESE |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | May 5, 1989 | SESE |
| K875018 | GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | Jan 28, 1988 | SESE |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | Dec 30, 1987 | SESE |
| K862160 | CAMINO HAND DRILL - MODEL 030 | Camino Laboratories, Inc. | Jul 18, 1986 | SESE |
Top Applicants
- Mri Interventions, Inc. — 3 clearances
- Neurodynamics, Inc. — 2 clearances
- Pudenz-Schulte Medical Research Corp. — 2 clearances
- Camino Laboratories, Inc. — 1 clearance
- Clinical Neuro Systems, LLC — 1 clearance
