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ENDOSOUND INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30179689933017968993ENDOSOUND INC1N2026-01-014640 S Macadam Ave Ste 200 Portland OR US 97239

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850050934097EndoSound® 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: 9.5mmWall Thickness: 1.25mm(971) 231-4791info@endosound.com
00850050934103EndoSound® 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: 9.3mmWall Thickness: 0.7mm(971) 231-4791info@endosound.com
00850050934110EndoSound® 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.(971) 231-4791info@endosound.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3246331308521362K250145Biopsy Port AdapterODC2025-10-17
3246331261675962K232518EndoSound Vision System; EVSODG2023-12-27
3246331035911560

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODC12025-10-17
ODG12023-12-27

PMN#

GUDID#