Atlas FDA

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

FDA 510(k) clearance K223616 · decided 2022-12-30

Clearance details

K-number
K223616
Device name
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2022-12-05
Decision date
2022-12-30
Days to decision
25 days
Clearance type
Special
Product code
ODG
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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