Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device— 510(k) K160845

Name: FDA 510(k) clearance K160845
Creator: U.S. Food and Drug Administration
Published: 2016-05-03

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K160845 for Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, Substantially Equivalent on 2016-05-03. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code ODG
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-28
Decision date: 2016-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODG

view all

K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)2026-07-31
K260428 — RIVOS EUS Access Device (M00553900)2026-06-17
K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)2025-10-03
K251542 — InstaFAN2025-07-18
K231813 — Ultrasonic Gastrovideoscope2024-03-08

More clearances from Boston Scientific Corporation

view all

K262151 — SpaceOAR Flex System2026-09-11
K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K261488 — OBSIDIO Conformable Embolic2026-07-24
K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.