Atlas FDA

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device

FDA 510(k) clearance K172565 · decided 2017-12-20

Clearance details

K-number
K172565
Device name
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2017-08-25
Decision date
2017-12-20
Days to decision
117 days
Clearance type
Traditional
Product code
PWJ
Device class
2
Regulation number
884.4910
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.

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