Panels › General, Plastic Surgery › Product code PAH · Class 2
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Regulation 878.3300
0510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PAH
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems | 5 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Caldera Medical, Inc. | 2 | 0 |
| Coloplast A/S | 2 | 0 |
| Mpathy Medical Devices, Ltd. | 2 | 0 |
| Astora | 0 | 1 |
| Boston Scientific Corp | 1 | 0 |
| Coloplast Corp. | 1 | 0 |
| ETHICON, Inc. | 1 | 0 |
| Gyne Ideas , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2024 | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System ( Coloplast Corp. | PAH |
| Feb 15, 2023 | K221874 | Altis Single Incision Sling System Coloplast A/S | PAH |
| Feb 7, 2020 | K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack Caldera Medical, Inc. | PAH |
| Nov 5, 2012 | K121562 | ALTIS SINGLE INCISION CLING SYSTEM Coloplast A/S | PAH |
| Nov 2, 2012 | K123179 | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING C.R. Bard, Inc. | PAH |
| Sep 7, 2012 | K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM American Medical Systems | PAH |
| May 8, 2012 | K110420 | OPHIRA MINI SLING SYSTEM Promedon S.A | PAH |
| Nov 30, 2011 | K103418 | DESARA MINI Caldera Medical, Inc. | PAH |
| Jun 7, 2010 | K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 American Medical Systems, Inc. | PAH |
| Nov 20, 2009 | K092607 | AJUST ADJUSTABLE SINGLE INCISION SLING C.R. Bard, Inc. | PAH |
| Jul 14, 2009 | K091180 | MINITAPE URETHRAL SLING Mpathy Medical Devices, Ltd., GB | PAH |
| Aug 27, 2008 | K081275 | BOSTON SCIENTIFIC SURGICAL MESH Boston Scientific Corp | PAH |
| Feb 25, 2008 | K073646 | MINITAPE URETHRAL SLING Mpathy Medical Devices, Ltd. | PAH |
| Jan 30, 2008 | K073703 | AMS MINIARC SLING SYSTEM American Medical Systems, Inc. | PAH |
| Aug 24, 2007 | K071902 | AMS MINIARC SLING SYSTEM American Medical Systems, Inc. | PAH |
| Mar 1, 2007 | K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) American Medical Systems, Inc. | PAH |
| Dec 19, 2006 | K063136 | NEEDLELESS SLING Specialities Remeex International, S.L. | PAH |
| Nov 28, 2005 | K052401 | GYNECARE TVT SECUR SYSTEM ETHICON, Inc. | PAH |
| Jun 18, 2003 | K023898 | GYNE IDEAS MINITAPE RP DEVICE Gyne Ideas , Ltd. | PAH |
| May 15, 2002 | K020652 | HERNIAMESH T-SLING Herniamesh | PAH |
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