PAH · Class II · 21 CFR 878.3300

FDA Product Code PAH: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.

Leading manufacturers include Coloplast A/S and Coloplast Corp..

2
Total
2
Cleared
146d
Avg days
2023
Since

List of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Oct 18, 2024
Altis Single Incision Sling System (519650)
K242473
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Feb 15, 2023
Altis Single Incision Sling System
K221874
Coloplast A/S
Gastroenterology & Urology · 232d

How to use this database

This page lists all FDA 510(k) submissions for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling devices (product code PAH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →