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ELECTRODE COATED BALL - Needle, Model An301c
FDA 510(k)Class II (US FDA 510(k))
510(k) K061878
Identifiers
- 510(k) Number
- K061878 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- Electrode Coated Ball, Model Ab302c FDA 510(k)Needle, Model An301c FDA 510(k)Blade, Model Ae301hc 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)
ELECTRODE COATED BALL - Needle, Model An301c by E Surgical, LLC — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS
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 | K061878 | Class II | Active |
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Manufacturer
- Manufacturer
- E Surgical, LLC
Sources (1)
- FDA 510(k) K061878 24 fields · synced Jun 18, 2026