Biopsy Port Adapter— 510(k) K250145

Substantially Equivalent

Endosound, Inc.

FDA 510(k) clearance K250145 for Biopsy Port Adapter, Substantially Equivalent on 2025-10-17. Applicant: Endosound, Inc..

Clearance details

Applicant: Endosound, Inc.
Product code: Code ODC
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-21
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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