ArcTO Transobturator Sling System

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

UroCure LLC

The following data is part of a premarket notification filed by Urocure Llc with the FDA for Arcto Transobturator Sling System.

Pre-market Notification Details

Device IDK222468
510k NumberK222468
Device Name:ArcTO Transobturator Sling System
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant UroCure LLC 701 North 3rd Street, Suite 110 Minneapolis,  MN  55401
ContactJohn Nealon
CorrespondentDenise Lenz
Libra Medical Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park,  MN  55428
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-16
Decision Date2022-09-15

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.