Identity
- Trade Name
- EndoSound® Ultrasound Transducer Module (UTM) FDA UDI
- Generic Name
- Flexible endoscopic ultrasound imaging transducer FDA UDI
- Device Name
- EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy. FDA UDI
- Model / Reference
- 5016 FDA UDI
- Description
- EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy. FDA UDI
Identifiers
- Catalog Number
- 5016 FDA UDI
- Primary DI / UDI-DI
- 00850050934165 FDA UDI
- 510(k) Number
- K232518 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Flexible endoscopic ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible endoscopic ultrasound imaging transducer
EndoSound® Ultrasound Transducer Module (UTM) by Endosound, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic ultrasound imaging transducer.
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC PROBE — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K232518 also covers:
- EndoSound® EVSScanner — Endosound, Inc.
- EndoSound® EVS™ Band Applicator — Endosound, Inc.
- EndoSound® EVS™ Bands — Endosound, Inc.
- EndoSound® Transducer Extension Connector (TEC) — Endosound, Inc.
- EndoSound® Ultrasound Disposable Kit (UDK-T) 5004 — Endosound, Inc.
- EndoSound® Ultrasound Disposable Kit (UDK-T) 5006 — Endosound, Inc.
- EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 — Endosound, Inc.
- EndoSound® Ultrasound Disposable Kit (UDK-T) 5010 — Endosound, Inc.
- EndoSound® Ultrasound Transducer Module (UTM) — Endosound, Inc.
- EndoSound® Vision System (EVS) Software — Endosound, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Endosound, Inc.
Sources (1)
- FDA UDI b2eb1f89-c5c6-4600-a2a0-3e780c7e8755 37 fields · synced May 31, 2026