Product code GEI: 510(k) clearances and predicates
Product code GEI covers Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102). FDA lists 2319 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
2319 clearances on file under product code GEI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 55 |
| 2023 | 65 |
| 2024 | 59 |
| 2025 | 52 |
| 2026 so far | 42 |
Recent clearances
Newest GEI clearances in the FDA index, with applicant and decision date:
- K261959, Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102), applicant Stryker Instruments, decided 2026-09-17. FDA record
- K254196, HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136), applicant Ethicon Endo-Surgery, LLC, decided 2026-09-17. FDA record
- K261070, LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated, applicant Covidien, LLC, decided 2026-09-15. FDA record
- K254185, Potenza Prime, applicant Jeisys Medical Incorporated, decided 2026-09-11. FDA record
- K262364, Ellian Enigma RF Device, applicant Ellian Corp, decided 2026-09-02. FDA record
- K253859, Scarlet Pro (Scarlet Pro), applicant VIOL Co., Ltd., decided 2026-08-27. FDA record
- K252535, Inno-Switch Laparoscopic Instruments, applicant Taiwan Surgical Corporation, decided 2026-08-25. FDA record
- K261179, AlphaTriPart - Monopolar MIC Instruments, applicant Gimmi GmbH, decided 2026-07-22. 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 HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136), LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated. Watch new GEI 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 GEI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GEI clearances include Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102).
How many 510(k) clearances use product code GEI?
2319 at the time this page was generated, from openFDA records.
How do I find a predicate device under GEI?
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 GEI 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.