Atlas FDA

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

FDA 510(k) clearance K231549 · decided 2023-06-29

Clearance details

K-number
K231549
Device name
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-05-30
Decision date
2023-06-29
Days to decision
30 days
Clearance type
Special
Product code
OTN
Device class
2
Regulation number
878.3300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
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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