Product code GWQ: 510(k) clearances and predicates
Product code GWQ covers Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32). FDA lists 189 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
189 clearances on file under product code GWQ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 6 |
| 2024 | 1 |
| 2025 | 0 |
| 2026 so far | 2 |
Recent clearances
Newest GWQ clearances in the FDA index, with applicant and decision date:
- K261604, Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32), applicant Neuroelectrics Barcelona S.L.U., decided 2026-06-13. FDA record
- K260455, New Wave System, applicant Zeto, Inc., decided 2026-03-13. FDA record
- K233403, Flexset System, applicant Zeto, Inc., decided 2024-04-30. FDA record
- K231366, Neuronaute Plus, applicant Bioserenity Sas, decided 2023-11-09. FDA record
- K221959, Q21, applicant Neurofield, Inc., decided 2023-08-31. FDA record
- K231457, SPARK Scan, applicant Spark Neuro, Inc., decided 2023-08-18. FDA record
- K221963, Cumulus Functional Neurophysiology Platform, applicant Cumulus Neuroscience Limited, decided 2023-04-27. FDA record
- K230073, Okti, applicant Compumedics Limited, decided 2023-02-09. 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 New Wave System, Flexset System. Watch new GWQ 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 GWQ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GWQ clearances include Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32).
How many 510(k) clearances use product code GWQ?
189 at the time this page was generated, from openFDA records.
How do I find a predicate device under GWQ?
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 GWQ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.