510(k) K160845

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device by Boston Scientific Corporation — Product Code ODG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 3, 2016
Date Received: March 28, 2016
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Endoscopic Ultrasound System, Gastroenterology-Urology
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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