PAH — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling Class II
Classification Details
- Product Code
- PAH
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242473 | coloplast | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 | October 18, 2024 |
| K221874 | coloplast | Altis Single Incision Sling System | February 15, 2023 |
| K191416 | caldera medical | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sli | February 7, 2020 |
| K121562 | coloplast | ALTIS SINGLE INCISION CLING SYSTEM | November 5, 2012 |
| K123179 | c.r. bard | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING | November 2, 2012 |
| K121641 | american medical systems | MINIARC PRO SINGLE-INCISION SLING SYSTEM | September 7, 2012 |
| K110420 | promedon | OPHIRA MINI SLING SYSTEM | May 8, 2012 |
| K103418 | caldera medical | DESARA MINI | November 30, 2011 |
| K100807 | american medical systems | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 | June 7, 2010 |
| K092607 | c.r. bard | AJUST ADJUSTABLE SINGLE INCISION SLING | November 20, 2009 |
| K091180 | mpathy medical devices | MINITAPE URETHRAL SLING | July 14, 2009 |
| K081275 | boston scientific | BOSTON SCIENTIFIC SURGICAL MESH | August 27, 2008 |
| K073646 | mpathy medical devices | MINITAPE URETHRAL SLING | February 25, 2008 |
| K073703 | american medical systems | AMS MINIARC SLING SYSTEM | January 30, 2008 |
| K071902 | american medical systems | AMS MINIARC SLING SYSTEM | August 24, 2007 |
| K070065 | american medical systems | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | March 1, 2007 |
| K063136 | specialities remeex international, s.l | NEEDLELESS SLING | December 19, 2006 |
| K052401 | ethicon | GYNECARE TVT SECUR SYSTEM | November 28, 2005 |
| K023898 | gyne ideas | GYNE IDEAS MINITAPE RP DEVICE | June 18, 2003 |
| K020652 | herniamesh | HERNIAMESH T-SLING | May 15, 2002 |