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.
Summary
Ascblue (model 8010) was filed under product code GEI — electrosurgical cutting and coagulation devices, which covers generator-plus-handpiece systems used for intraoperative tissue cutting and hemostasis. The device_name is generic and the filing metadata provides no further product detail.
General, Plastic Surgery panel, Traditional 510(k). GEI is one of the highest-volume device categories — thousands of cleared devices span energy-based surgical equipment from basic bipolar forceps to advanced radiofrequency platforms. The substantial equivalence argument for a basic electrosurgical unit is well-trodden.
Ascblue Corporation files from Brea, CA. Roughly four-month review clock, short for Traditional 510(k) — likely reflecting a clean predicate comparison on a mature device category.
Clearance details
- Applicant
- Ascblue Corporation
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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.