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Caldera Medical Transobturator Helical Introducer, Left - Caldera Medical Transobturator Large Helical Introducer, Left
FDA 510(k)Class II (US FDA 510(k))
510(k) K172614
Identifiers
- 510(k) Number
- K172614 FDA 510(k)
- FDA Product Code
- PWJ FDA 510(k)
- Models / Variants
- Caldera Medical Transobturator Large Helical Introducer, Left FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4910 FDA 510(k)
- Regulation Number
- 884.4910 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Caldera Medical Transobturator Helical Introducer, Left - Caldera Medical Transobturator Large Helical Introducer, Left by Caldera Medical, Inc. — Class II…
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 | K172614 | Class II | Active |
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Manufacturer
- Manufacturer
- Caldera Medical, Inc.
Sources (1)
- FDA 510(k) K172614 24 fields · synced Jun 18, 2026