Data / Medical devices / United States / Endosound Inc

Endosound Inc: FDA-registered device maker in Portland, OR, United States, 2 510(k) clearances

Name: Endosound Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Endosound Inc is registered with the FDA (registration 3017968993) in Portland, OR, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017968993
Address: 4640 S Macadam Ave Ste 200, Portland, OR, United States, 97239
Owner or operator: EndoSound Inc (10089762)
Roles: Complaint file establishment, Manufacturer
First device listed: January 5, 2024
Registered through: 2026
Brand names listed: Air Leakage Tester, Biopsy Port Adapter, EndoSound Vision System

Devices it lists

Device	Product code	Class	Role	Source
Bulb, Inflation, For Endoscope	FCY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 17, 2025	K250145	Biopsy Port Adapter	ODC	Substantially Equivalent	Endosound, Inc.	accessdata.fda.gov
December 27, 2023	K232518	EndoSound Vision System; EVS	ODG	Substantially Equivalent	Endosound, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.