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Magnum Core Tissue Biopsy Needle (Mn1820 +2 more) - Mcn Core Tissue Biopsy Needle Model Mcn-
FDA 510(k)Class II (US FDA 510(k))
510(k) K111529
Identifiers
- 510(k) Number
- K111529 FDA 510(k)
- FDA Product Code
- KNW FDA 510(k)
- Models / Variants
- Mn1820 FDA 510(k)Rp Cutting Needle Model Rp-1820 FDA 510(k)Mcn Core Tissue Biopsy Needle Model Mcn- 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)
Magnum Core Tissue Biopsy Needle (Mn1820 +2 more) - Mcn Core Tissue Biopsy Needle Model Mcn- by Insert Molding Solutions, Inc. — Class II — FDA_510K — listed…
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 | K111529 | Class II | Active |
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Manufacturer
- Manufacturer
- Insert Molding Solutions, Inc.
Sources (1)
- FDA 510(k) K111529 24 fields · synced Jun 18, 2026