Atlas FDA

LithoVue System

FDA 510(k) clearance K153049 · decided 2015-11-13

Clearance details

K-number
K153049
Device name
LithoVue System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2015-10-20
Decision date
2015-11-13
Days to decision
24 days
Clearance type
Traditional
Product code
FGB
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlborough, MA, US
Third-party review
Yes
Expedited review
No

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No recalls on record reference this clearance.

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