Product code GCJ: 510(k) clearances and predicates
Product code GCJ covers CuratOR EX2742. FDA lists 1430 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
1430 clearances on file under product code GCJ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 20 |
| 2023 | 31 |
| 2024 | 29 |
| 2025 | 21 |
| 2026 so far | 25 |
Recent clearances
Newest GCJ clearances in the FDA index, with applicant and decision date:
- K262397, CuratOR EX2742, applicant Eizo Corporation, decided 2026-09-11. FDA record
- K260884, UNIDRIVE Select System, applicant Karl Storz SE & CO. KG, decided 2026-09-01. FDA record
- K260972, OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor, applicant Sony Corporation, decided 2026-08-26. FDA record
- K261139, VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103), applicant Freyja Healthcare, LLC, decided 2026-08-13. FDA record
- K253541, EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device), applicant Medical Impact, decided 2026-07-24. FDA record
- K261614, LED LCD Monitor (OEV-271H), applicant Lg Electronics.Inc, decided 2026-07-17. FDA record
- K261249, Universal Seal (5-12 mm), applicant Intuitive Surgical, Inc., decided 2026-07-14. FDA record
- K260710, FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air), applicant FloShield, Inc., decided 2026-06-11. 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 UNIDRIVE Select System, OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor. Watch new GCJ 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 GCJ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GCJ clearances include CuratOR EX2742.
How many 510(k) clearances use product code GCJ?
1430 at the time this page was generated, from openFDA records.
How do I find a predicate device under GCJ?
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 GCJ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.