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Flexible Suction Ureterorenoscope (US27G-12-EU +5 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K252806
Identifiers
- 510(k) Number
- K252806 FDA 510(k)
- FDA Product Code
- FGB FDA 510(k)
- Models / Variants
- US27G-12-EU FDA 510(k)US27G-12-US FDA 510(k)US33G-17-EU FDA 510(k)US33G-17-US FDA 510(k)US38G-20-EU FDA 510(k)US38G-20-US. 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)
Flexible Suction Ureterorenoscope (US27G-12-EU +5 more) by Shanghai Anqing Medical Instrument Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 6 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 | K252806 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- FDA Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Sources (1)
- FDA 510(k) K252806 24 fields · synced Jun 20, 2026