Ascblue (8010)— 510(k) K253777
Substantially EquivalentAscblue Corporation
FDA 510(k) clearance K253777 for Ascblue (8010), Substantially Equivalent on 2026-04-10. Applicant: Ascblue Corporation. Device class: 2.
Summary
Ascblue (model 8010) is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The device name is just the company name plus a model number, and the record doesn't say whether this is a generator or an accessory.
Class II, 21 CFR 878.4400. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Ascblue Corporation filed from Brea, California. Review took 135 days (November 26, 2025 to April 10, 2026).
Clearance details
- Applicant
- Ascblue Corporation
- 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
- Brea, CA, 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.