Cleared Traditional

Capio SLIM Suture Capturing Device

K172060 · Boston Scientific Corporation · Obstetrics & Gynecology
Nov 2017
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K172060 is an FDA 510(k) clearance for the Capio SLIM Suture Capturing Device, a Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse (Class II — Special Controls, product code PWI), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on November 3, 2017, 119 days after receiving the submission on July 7, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4910.

Submission Details

510(k) Number K172060 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2017
Decision Date November 03, 2017
Days to Decision 119 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PWI — Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4910
Definition Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair