Atlas FDA

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller

FDA 510(k) clearance K200483 · decided 2020-05-21

Clearance details

K-number
K200483
Device name
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2020-02-27
Decision date
2020-05-21
Days to decision
84 days
Clearance type
Traditional
Product code
FBN
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.

PMA approvals by this applicant

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