FDA 510(k)

Acquire™ S 内窥镜超声细针穿刺活检（FNB）设备

K号: K223616 · 2022-12-30

决定日期2022-12-30

产品代码ODG

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决定实质等同

器械摘要

Acquire™ S 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 2022-12-30 under 510(k) number K223616. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Boston Scientific Corporation. The 510(k) number is K223616.

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

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device received FDA 510(k) clearance on 2022-12-30, under 510(k) number K223616.

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

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

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

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

列明Boston Scientific Corporation为申报人的其他记录

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