← Back to catalogue
Endoscopic Ultrasonic Probe - Endoscopic Ultrasonic Probe (P2612S-L)
FDA 510(k)Class II (US FDA 510(k))
510(k) K231666
Identifiers
- 510(k) Number
- K231666 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
- Models / Variants
- Endoscopic Ultrasonic Probe (P2612S-L) FDA 510(k)Endoscopic Ultrasonic Probe (P2620S-L) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Endoscopic Ultrasonic Probe - Endoscopic Ultrasonic Probe (P2612S-L) by FUJIFILM Healthcare Americas Corporation — Class II — FDA_510K — listed in FDA 510(k)…
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 | K231666 | 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) K231666 24 fields · synced Jun 18, 2026