← Back to catalogue
Over-tube (TR-1208A) +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K230752
Identifiers
- 510(k) Number
- K230752 FDA 510(k)
- FDA Product Code
- FED FDA 510(k)
- Models / Variants
- Over-tube (TR-1208A) FDA 510(k)Over-tube (TR-1504A) FDA 510(k)Over-tube (TR-1507A) 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)
Over-tube (TR-1208A) +2 more models by FUJIFILM Healthcare Americas Corporation — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K230752 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
Sources (1)
- FDA 510(k) K230752 24 fields · synced Jun 18, 2026