PAH — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling Class II
FDA product code PAH covers "Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |