HBG — Drills, Burrs, Trephines & Accessories (Manual) Class II
FDA product code HBG covers "Drills, Burrs, Trephines & Accessories (Manual)", a Class II medical device regulated under 21 CFR 882.4300. Submissions are reviewed by the Neurology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HBG
- Device Class
- Class II
- Regulation Number
- 882.4300
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252696 | phasor health | LEGACY | November 21, 2025 |
| K153587 | synthes (usa) products | Taps for Resorbable Screws | January 18, 2017 |
| K162884 | spineguard | SpineGuard DSG Zavation Screw System | January 12, 2017 |
| K160129 | mri interventions | MRII Cranial Drill and Accessories | March 26, 2016 |
| K151536 | mri interventions | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | July 8, 2015 |
| K122456 | mri interventions | MRII CRAINIAL DRILL | March 22, 2013 |
| K022712 | medical design | HAND DRILL, MODEL 11-9901-7 | November 12, 2002 |
| K022370 | medtronic xomed | FRAMELOCK; FRAMELOCK ACCESSORIES | October 18, 2002 |
| K961113 | clinical neuro systems | CNS INTERCHANGEABLE BIT CRANIAL DRILL | June 5, 1996 |
| K932402 | neurodynamics | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | August 5, 1993 |
| K915546 | pudenz-schulte medical research | PS MEDICAL VENTRICULOSTOMY KIT | December 30, 1991 |
| K904283 | pudenz-schulte medical research | PS MEDICAL CRANIAL HAND DRILL | October 3, 1990 |
| K902818 | ruggles | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | September 20, 1990 |
| K892531 | zinnanti surgical instruments | NEUROSURGICAL DRILLS: STILLE, HUDSON | May 5, 1989 |
| K875018 | neurodynamics | GHAJAR GUIDE TWIST DRILL | January 28, 1988 |
| K874952 | solway | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | December 30, 1987 |
| K862160 | camino laboratories | CAMINO HAND DRILL - MODEL 030 | July 18, 1986 |