Identifiers
- 510(k) Number
- K252513 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
- Models / Variants
- Polywin Safety (14G x 51mm FDA 510(k)16G x 51mm FDA 510(k)18G x 64mm FDA 510(k)20G x 64mm FDA 510(k)20G x 45mm FDA 510(k)22G x 64mm FDA 510(k)22G x 45mm FDA 510(k)24G x 32mm FDA 510(k)24G x 14mm, 26G x 14mm) FDA 510(k)Polywin Safety Adva (20G x 45mm FDA 510(k)22G x 64mm FDA 510(k)22G x 45mm FDA 510(k)24G x 32 mm FDA 510(k)24G x 14mm FDA 510(k)14G x 51mm FDA 510(k)16G x 51mm FDA 510(k)18G x 64mm FDA 510(k)20G x 64mm, 26G x 14mm) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Polywin Safety - 24G x 32mm by Poly Medicure Limited — Class II — FDA_510K — listed in FDA 510(k) — 18 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 | K252513 | Class II | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
Sources (1)
- FDA 510(k) K252513 24 fields · synced Jun 19, 2026