Ellian Enigma RF Device— 510(k) K262364
Substantially EquivalentEllian Corp
FDA 510(k) clearance K262364 for Ellian Enigma RF Device, Substantially Equivalent on 2026-09-02. Applicant: Ellian Corp. Device class: 2.
Summary
Ellian Enigma RF Device is from Ellian Corp, filed under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). The record doesn't describe the device beyond its name and code.
Class II, 21 CFR 878.4400. General, Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Ellian filed from Plano, Texas. The decision came 54 calendar days after FDA received it (July 10 to September 2, 2026).
Clearance details
- Applicant
- Ellian Corp
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.