HSA · registration DE0509417

Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

Name: Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device — HSA DE0509417
Creator: Boston Scientific Corporation
Keywords: Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, DE0509417, Gastroenterology & Urology, HSA

SingaporeGastroenterology & UrologyClass BBoston Scientific Corporation

Verified

Official record identity

Registration number: DE0509417
Model name: Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device; Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device; Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device; Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Model identifier: M00555640; M00555641; M00555660; M00555661
Registration date: June 20, 2024

Classification

Risk class: Class B
Published category: Gastroenterology & Urology

Published parties

Product owner: Boston Scientific Corporation
Registrant / registration holder: BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.

Official description

The Acquire Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Additional source fields

Product owner address: 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
Registrant address: 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.