PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | PAH |
|---|---|
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Coloplast Corp. | Oct 18, 2024 | SESE |
| K221874 | Altis Single Incision Sling System | Coloplast A/S | Feb 15, 2023 | SESE |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Caldera Medical, Inc. | Feb 7, 2020 | SESE |
| K121562 | ALTIS SINGLE INCISION CLING SYSTEM | Coloplast A/S | Nov 5, 2012 | SESE |
| K123179 | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING | C.R. Bard, Inc. | Nov 2, 2012 | SESE |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | American Medical Systems | Sep 7, 2012 | SESE |
| K110420 | OPHIRA MINI SLING SYSTEM | Promedon S.A | May 8, 2012 | SESE |
| K103418 | DESARA MINI | Caldera Medical, Inc. | Nov 30, 2011 | SESE |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 | American Medical Systems, Inc. | Jun 7, 2010 | SESE |
| K092607 | AJUST ADJUSTABLE SINGLE INCISION SLING | C.R. Bard, Inc. | Nov 20, 2009 | SESE |
| K091180 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | Jul 14, 2009 | SESE |
| K081275 | BOSTON SCIENTIFIC SURGICAL MESH | Boston Scientific Corp | Aug 27, 2008 | SESE |
| K073646 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | Feb 25, 2008 | SESE |
| K073703 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | Jan 30, 2008 | SESE |
| K071902 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | Aug 24, 2007 | SESE |
| K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | American Medical Systems, Inc. | Mar 1, 2007 | SESE |
| K063136 | NEEDLELESS SLING | Specialities Remeex International, S.L. | Dec 19, 2006 | SESE |
| K052401 | GYNECARE TVT SECUR SYSTEM | ETHICON, Inc. | Nov 28, 2005 | SESE |
| K023898 | GYNE IDEAS MINITAPE RP DEVICE | Gyne Ideas , Ltd. | Jun 18, 2003 | SESE |
| K020652 | HERNIAMESH T-SLING | Herniamesh | May 15, 2002 | SESE |
Top Applicants
- American Medical Systems, Inc. — 4 clearances
- Mpathy Medical Devices, Ltd. — 2 clearances
- Coloplast A/S — 2 clearances
- Caldera Medical, Inc. — 2 clearances
- C.R. Bard, Inc. — 2 clearances
