FDA product code HBG: Drills, Burrs, Trephines & Accessories (Manual)
HBG is the FDA product code for drills, burrs, trephines & accessories (manual). It is a Class II device, regulated under 21 CFR 882.4300 and reviewed by the Neurology panel. FDA has cleared 17 510(k) submissions under HBG, 1 in the last five years, from 13 different applicants. The average 510(k) review took 90 days (median 77); 86 days on average over the last three years. FDA has posted 54 recalls for HBG devices, 22 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Drills, Burrs, Trephines & Accessories (Manual) |
| Device class | Class II |
| Regulation | 21 CFR 882.4300 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 244 |
| 2025 | 1 | 86 |
Compare with all 510(k) review times · Search every HBG clearance
Top HBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mri Interventions, Inc. | 3 | 2016-03-26 |
| Neurodynamics, Inc. | 2 | 1993-08-05 |
| Pudenz-Schulte Medical Research Corp. | 2 | 1991-12-30 |
| Phasor Health, LLC | 1 | 2025-11-21 |
| Synthes (USA) Products, LLC | 1 | 2017-01-18 |
8 more applicants have HBG clearances. See the full list in Caduvo.
Most recent HBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252696 | Phasor Health, LLC | LEGACY | 2025-11-21 | 86 |
| K153587 | Synthes (USA) Products, LLC | Taps for Resorbable Screws | 2017-01-18 | 399 |
| K162884 | Spineguard S.A. | SpineGuard DSG Zavation Screw System | 2017-01-12 | 90 |
| K160129 | Mri Interventions, Inc. | MRII Cranial Drill and Accessories | 2016-03-26 | 66 |
| K151536 | Mri Interventions, Inc. | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | 2015-07-08 | 30 |
Recalls for HBG devices
54 product recalls in 12 recall events; 22 initiated in the last five years and 22 still open. Most recent: 2026-06-17.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 9 |
| 2024 | 12 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HBG?
HBG is the FDA product code for drills, burrs, trephines & accessories (manual). It is a Class II device, regulated under 21 CFR 882.4300 and reviewed by the Neurology panel.
What device class is HBG?
Class II, regulation 21 CFR 882.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBG?
Across 17 cleared submissions the average was 90 days from receipt to decision (median 77).
Which companies have the most HBG clearances?
Mri Interventions, Inc. (3); Neurodynamics, Inc. (2); Pudenz-Schulte Medical Research Corp. (2); Phasor Health, LLC (1); Synthes (USA) Products, LLC (1).
Have HBG devices been recalled?
Yes: 54 product recalls across 12 recall events; the most recent began 2026-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code HBG
- Run a recall and safety report across every HBG manufacturer
- Watch product code HBG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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