FDA 510(k)

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

K-Number: K160845 · 2016-05-03

Decision Date2016-05-03

Product CodeODG

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-05-03 under approval number K160845. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a medical device that received FDA 510(k) clearance on 2016-05-03. It is manufactured by Boston Scientific Corporation. The 510(k) number is K160845.

When was Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device approved by the FDA?

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device received FDA 510(k) clearance on 2016-05-03, under approval number K160845.

What company makes Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is manufactured by Boston Scientific Corporation.

What is the FDA product code for Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

The FDA product code for Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is ODG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.