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Duoblade Plus SE - Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
FDA 510(k)Class II (US FDA 510(k))
510(k) K252211
Identifiers
- 510(k) Number
- K252211 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Duoblade Plus SE - Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) by Cnc Technologies — Class II — FDA_510K — listed in FDA 510(k) — 2 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252211 | Class II | Active |
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Manufacturer
- Manufacturer
- Cnc Technologies
Sources (1)
- FDA 510(k) K252211 24 fields · synced Jun 19, 2026