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Precisecore 10 Mm Biopsy Device- 14ga X 5 Cm (670514 +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K093399
by Inrad
Identifiers
- 510(k) Number
- K093399 FDA 510(k)
- FDA Product Code
- KNW FDA 510(k)
- Models / Variants
- 670514 FDA 510(k)671014 FDA 510(k)670518 671018 FDA 510(k)670520 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1075 FDA 510(k)
- Regulation Number
- 876.1075 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Precisecore 10 Mm Biopsy Device- 14ga X 5 Cm (670514 +3 more) by Inrad — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K093399 | Class II | Active |
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Manufacturer
- Manufacturer
- Inrad
Sources (1)
- FDA 510(k) K093399 24 fields · synced Jun 19, 2026