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Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope +14 …
FDA 510(k)Class II (US FDA 510(k))
510(k) K251652
Identifiers
- 510(k) Number
- K251652 FDA 510(k)
- FDA Product Code
- FAJ FDA 510(k)
- Models / Variants
- STS-2040-302ASA HD-endoscope FDA 510(k)STS-2040-302AA HD-endoscope FDA 510(k)STS-2040-302BA HD-endoscope FDA 510(k)STS-2040-302BSA HD-endoscope FDA 510(k)STS-2040-302ESA HD-endoscope FDA 510(k)STS-2040-302CA HD-endoscope FDA 510(k)STS-2029-302AA HD-endoscope FDA 510(k)STS-2029-302BA HD-endoscope FDA 510(k)STS-2040-298DSA-RWF-endoscope FDA 510(k)STS-2040-298ASA-RWF-endoscope FDA 510(k)STS-2040-300GSA-RWF-endoscope FDA 510(k)STS-2040-303CA-RWF-endoscope FDA 510(k)STS-2040-280ASA-OLY-endoscope FDA 510(k)STS-2040-280ESA-OLY-endoscope FDA 510(k)STS-2040-283BSA-OLY-endo FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope +14 … by American Medical Endoscopy, Inc. — Class II — FDA_510K — listed in FDA…
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 | K251652 | Class II | Active |
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Manufacturer
- Manufacturer
- American Medical Endoscopy, Inc.
Sources (1)
- FDA 510(k) K251652 24 fields · synced Jun 18, 2026