FDA.reportPublic FDA data

510(k) K231549

Device
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Applicant
Boston Scientific Corporation
510(k) number
K231549
Product code
OTN
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-29
Date received
2023-05-30
Regulation
878.3300
Classification name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jotham Moon
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K132069DESARA MESH, DESARA BLUECaldera Medical, Inc.2013-09-23
K132054GYNECARE TVT EXACT CONTINENCE SYSTEMETHICON, Inc.2013-08-23
K121928DESARA SLCaldera Medical, Inc.2013-02-19
K121754BLUE SUI SLINGBoston Scientific Corp2012-10-10