Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)— 510(k) K252211

Name: FDA 510(k) clearance K252211
Creator: U.S. Food and Drug Administration
Published: 2025-08-11

Substantially Equivalent

Cnc Technologies

FDA 510(k) clearance K252211 for Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH), Substantially Equivalent on 2025-08-11. Applicant: Cnc Technologies. Device class: 2.

Clearance details

Applicant: Cnc Technologies
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-07-15
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Gwangmyeong-Si, KR

Download summary PDF View on FDA.gov ↗

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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, 2020-01-01 through 2026-04-23. 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.