FDA product code HAW: Neurological Stereotaxic Instrument
HAW is the FDA product code for neurological stereotaxic instrument. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel. FDA has cleared 425 510(k) submissions under HAW, 41 in the last five years, from 151 different applicants. The average 510(k) review took 141 days (median 115); 171 days on average over the last three years. FDA has posted 197 recalls for HAW devices, 18 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Neurological Stereotaxic Instrument |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for HAW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 221 |
| 2018 | 6 | 122 |
| 2019 | 10 | 150 |
| 2020 | 5 | 168 |
| 2021 | 9 | 207 |
| 2022 | 7 | 167 |
| 2023 | 14 | 201 |
| 2024 | 7 | 100 |
| 2025 | 9 | 243 |
| 2026 | 4 | 169 |
Compare with all 510(k) review times · Search every HAW clearance
Top HAW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brainlab AG | 57 | 2025-01-28 |
| Medtronic Navigation, Inc. | 18 | 2026-03-26 |
| Elekta Instrument AB | 16 | 2019-08-01 |
| Image-Guided Neurologics, Inc. | 15 | 2005-04-21 |
| Surgical Navigation Technologies, Inc. | 15 | 2000-02-22 |
146 more applicants have HAW clearances. See the full list in Caduvo.
Most recent HAW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253856 | Koh Young Technology, Inc. | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | 2026-09-10 | 281 |
| K261932 | Elekta Solutions AB | Leksell® Vantage Stereotactic System | 2026-08-05 | 57 |
| K253663 | Zeta Surgical, Inc. | Zeta Navigation System | 2026-05-01 | 162 |
| K253379 | Medtronic Navigation, Inc. | Stealth AXiS Cranial clinical application | 2026-03-26 | 177 |
| K231897 | Medivis, Inc. | NeuroAlign software | 2025-10-21 | 846 |
Recalls for HAW devices
197 product recalls in 114 recall events; 18 initiated in the last five years and 23 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 18 |
| 2019 | 6 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 7 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HAW?
HAW is the FDA product code for neurological stereotaxic instrument. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel.
What device class is HAW?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code HAW?
Across 425 cleared submissions the average was 141 days from receipt to decision (median 115).
Which companies have the most HAW clearances?
Brainlab AG (57); Medtronic Navigation, Inc. (18); Elekta Instrument AB (16); Image-Guided Neurologics, Inc. (15); Surgical Navigation Technologies, Inc. (15).
Have HAW devices been recalled?
Yes: 197 product recalls across 114 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HAW
- Run a recall and safety report across every HAW manufacturer
- Watch product code HAW 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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