Atlas FDA

Resolution Clip

FDA 510(k) clearance K151802 · decided 2015-08-06

Clearance details

K-number
K151802
Device name
Resolution Clip
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2015-07-02
Decision date
2015-08-06
Days to decision
35 days
Clearance type
Traditional
Product code
PKL
Device class
2
Regulation number
876.4400
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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