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510(k) K211223

Device
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Applicant
Boston Scientific Corporation
510(k) number
K211223
Product code
OTN  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-21
Date received
2021-04-23
Regulation
878.3300
Classification name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Medical specialty
General & Plastic Surgery
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rachel Nankervis
Address
300 Boston Scientific Way Marborough MA US 01752 01752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OTN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation2023-06-29
K222293ArcSP Suprapubic Sling SystemUrocure, LLC2022-09-21
K222468ArcTO Transobturator Sling SystemUrocure, LLC2022-09-15
K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.2021-11-10
K210087Athena Surgical RMUS SystemAthena Surgical, LLC2021-04-12
K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged GuideETHICON, Inc.2020-09-17
K183134ArcTV Transvaginal Sling SystemUrocure, LLC2019-02-07
K162201Desara TV, Desara Blue TVCaldera Medical, Inc.2017-01-11
K140843DESARA BLUE OV, DESARA BLUE SSCaldera Medical2014-07-01
K131229SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMSAmerican Medical Systems2013-12-05
K132655RETROARC RETROPUBIC SLING SYSTEMAmerican Medical Systems, Inc.2013-11-20
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

Legacy Summary#

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FDA Review#

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