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Desara One Single Incision Sling System, 1 Pack +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K191416
Identifiers
- 510(k) Number
- K191416 FDA 510(k)
- FDA Product Code
- PAH FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Desara One Single Incision Sling System, 1 Pack +1 more model by Caldera Medical, Inc. — 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 | K191416 | Class II | Active |
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Manufacturer
- Manufacturer
- Caldera Medical, Inc.
Sources (1)
- FDA 510(k) K191416 24 fields · synced Jun 18, 2026