The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Capio Slim Suture Capturing Device.
Device ID | K172060 |
510k Number | K172060 |
Device Name: | Capio SLIM Suture Capturing Device |
Classification | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
Contact | Rachel Nankervis |
Correspondent | Michelle Becker Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
Product Code | PWI |
CFR Regulation Number | 884.4910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-07 |
Decision Date | 2017-11-03 |
Summary: | summary |