PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Uppe…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200090 FDA 510(k)
- FDA Product Code
- ODG 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)
The EG-J10U Endoscopic Ultrasound System is a diagnostic imaging device designed for endoscopic ultrasound procedures. It integrates ultrasound imaging with flexible endoscopy to provide real-time visualization of abdominal and thoracic organs, including the gastrointestinal tract, pancreas, liver, and surrounding structures. The system features three scope types: the EG34-J10U (Convex Array Type), EG36-J10UR (Radial Array Type), and EG38-J10UT (Convex Array Type), each optimized for specific anatomical assessments.
This device is intended for use in clinical settings such as gastroenterology and urology, where high-resolution imaging is required. The scopes are reusable and require proper cleaning, disinfection, and sterilization as per manufacturer guidelines. The system is classified under FDA device class 2 and is authorized under the Medical Device Regulation (MDR) and FDA 510(k) clearance (K200090). Compliance with regulatory standards ensures safe and effective use in endoscopic ultrasound procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200090 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (2)
- FDA 510(k) K200090 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026