Cleared Traditional

BVI SLING

K002233 · Bio-Vascular, Inc. · Obstetrics & Gynecology
Oct 2000
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K002233 is an FDA 510(k) clearance for the BVI SLING, a Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (Class II — Special Controls, product code PAJ), submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 13, 2000, 81 days after receiving the submission on July 24, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K002233 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2000
Decision Date October 13, 2000
Days to Decision 81 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PAJ — Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition Bridging Material To Attach The Vaginal Apex Or Uterus To The Sacral Promontory; Procedures Include Abdominal Sacrocolpopexy, Laparoscopic Sacrocolpopexy And Robot-assisted Sacrocolpopexy.