Capio SLIM Suture Capturing Device

Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Capio Slim Suture Capturing Device.

Pre-market Notification Details

Device IDK172060
510k NumberK172060
Device Name:Capio SLIM Suture Capturing Device
ClassificationInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactRachel Nankervis
CorrespondentMichelle Becker
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodePWI  
CFR Regulation Number884.4910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-07
Decision Date2017-11-03
Summary:summary

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