Identity
- Trade Name
- EndoSound® EVS™ Bands FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- EndoSound® EVS™ Bands, is a disposable, single-use kit used to attach the UTM to compatible endoscopes. FDA UDI
- Model / Reference
- 18102 FDA UDI
- Description
- EndoSound® EVS™ Bands, is a disposable, single-use kit used to attach the UTM to compatible endoscopes. FDA UDI
Identifiers
- Catalog Number
- 5013 FDA UDI
- Primary DI / UDI-DI
- 00850050934141 FDA UDI
- 510(k) Number
- K232518 FDA UDI
- FDA Product Code
- ODG FDA UDIIYN FDA UDIIYO FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 9.5 Millimeter FDA UDI
Category: General-purpose ultrasound imaging system
EndoSound® EVS™ Bands by Endosound, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose ultrasound imaging system.
- SE12-3 Gen II® — SUPERSONIC IMAGINE · Class II
- SUPERSONIC MACH 40 — SUPERSONIC IMAGINE · Class II
- HS50 — SAMSUNG MEDISON CO., LTD · Class II
- EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd. · Class II
- Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- MEDISONO — Medisono, LLC · Class II
Cleared under the same submission
K232518 also covers:
- EndoSound® EVSScanner — Endosound, Inc.
- EndoSound® EVS™ Band Applicator — 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® 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endosound, Inc.
Sources (1)
- FDA UDI 848c5a35-870f-412f-b060-3b26bf38e1c6 38 fields · synced Jun 6, 2026