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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-05-03 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K160845.

When did Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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.