Product code HAW: 510(k) clearances and predicates
Product code HAW covers Geniant Cranial (Navigated Neurosurgical Positioning Robot). FDA lists 425 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
425 clearances on file under product code HAW. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 14 |
| 2024 | 7 |
| 2025 | 9 |
| 2026 so far | 4 |
Recent clearances
Newest HAW clearances in the FDA index, with applicant and decision date:
- K253856, Geniant Cranial (Navigated Neurosurgical Positioning Robot), applicant Koh Young Technology, Inc., decided 2026-09-10. FDA record
- K261932, Leksell® Vantage Stereotactic System, applicant Elekta Solutions AB, decided 2026-08-05. FDA record
- K253663, Zeta Navigation System, applicant Zeta Surgical, Inc., decided 2026-05-01. FDA record
- K253379, Stealth AXiS Cranial clinical application, applicant Medtronic Navigation, Inc., decided 2026-03-26. FDA record
- K231897, NeuroAlign software, applicant Medivis, Inc., decided 2025-10-21. FDA record
- K251317, SOLOPASS 2.0 System, applicant Intravent Medical Partners, decided 2025-09-05. FDA record
- K250893, Ball Joint Guide Array (66295), applicant Bayer Medical Care, Inc., decided 2025-09-04. FDA record
- K250505, EZ-FIDUCIALS, applicant Phasor Health, LLC, decided 2025-07-09. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Leksell® Vantage Stereotactic System, Zeta Navigation System. Watch new HAW clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HAW?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HAW clearances include Geniant Cranial (Navigated Neurosurgical Positioning Robot).
How many 510(k) clearances use product code HAW?
425 at the time this page was generated, from openFDA records.
How do I find a predicate device under HAW?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HAW clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.