endosound.comEndoSound Vision System; EVS
Endosound, Inc.
ENDOSOUND INC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017968993 | 3017968993 | ENDOSOUND INC | 1 | N | 2026-01-01 | 4640 S Macadam Ave Ste 200 Portland OR US 97239 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850050934080 | EndoSound® Ultrasound Disposable Kit (UDK-T) 5006 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm | (971) 231-4791 | info@endosound.com |
| 00850050934097 | EndoSound® Ultrasound Disposable Kit (UDK-T) 5010 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm | (971) 231-4791 | info@endosound.com |
| 00850050934103 | EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm | (971) 231-4791 | info@endosound.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 324633 | 1308521362 | K250145 | Biopsy Port Adapter | ODC | 2025-10-17 |
| 324633 | 1261675962 | K232518 | EndoSound Vision System; EVS | ODG | 2023-12-27 |
| 324633 | 1035911560 |
Product Codes Associated With Registrations
PMN
GUDID
EndoSound® Ultrasound Transducer Module (UTM) - EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
2024-10-31
EndoSound® EVS™ Band Applicator - EndoSound® EVS™ Band Applicator. EndoSound® EVS™ Bands is a disposable, single-use kit used to attach the UTM to compatible endoscopes.
2024-08-30
EndoSound® EVS™ Bands - EndoSound® EVS™ Bands, is a disposable, single-use kit used to attach the UTM to compatible endoscopes.
2024-06-14
EndoSound® Vision System (EVS) Software - The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC's monitor.
2024-01-30
EndoSound® Air Leak Tester - The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.
2024-01-30
EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm
2024-01-30
EndoSound® Ultrasound Disposable Kit (UDK-T) 5010 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm
2024-01-30
EndoSound® Ultrasound Disposable Kit (UDK-T) 5006 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
2024-01-30
EndoSound® Ultrasound Disposable Kit (UDK-T) 5004 - EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 10.5mm Wall Thickness: 0.5mm
2024-01-30
EndoSound® Ultrasound Transducer Module (UTM) - EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
2024-01-30
EndoSound® EVSScanner - The EndoSound Vision System (EVS) Scanner is a small, portable, self-contained module that contains the electronics that perform ultrasound scanning and receiving functions (beamforming).
2024-01-30
EndoSound® Transducer Extension Connector (TEC) - The EndoSound Transducer Extension Connector (TEC) includes the electrical connectors and cable between the EVSScanner and the UTM.
2024-01-30