Product code PAH

Device name: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.3300
Review panel: GU
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242473	Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)	Coloplast Corp.	2024-10-18
K221874	Altis Single Incision Sling System	Coloplast A/S	2023-02-15
K191416	Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack	Caldera Medical, Inc.	2020-02-07
K121562	ALTIS SINGLE INCISION CLING SYSTEM	Coloplast A/S	2012-11-05
K123179	AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING	C.R. Bard, Inc.	2012-11-02
K121641	MINIARC PRO SINGLE-INCISION SLING SYSTEM	American Medical Systems	2012-09-07
K110420	OPHIRA MINI SLING SYSTEM	Promedon S.A	2012-05-08
K103418	DESARA MINI	Caldera Medical, Inc.	2011-11-30
K100807	MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191	American Medical Systems, Inc.	2010-06-07
K092607	AJUST ADJUSTABLE SINGLE INCISION SLING	C.R. Bard, Inc.	2009-11-20
K091180	MINITAPE URETHRAL SLING	Mpathy Medical Devices, Ltd.	2009-07-14
K081275	BOSTON SCIENTIFIC SURGICAL MESH	Boston Scientific Corp	2008-08-27
K073646	MINITAPE URETHRAL SLING	Mpathy Medical Devices, Ltd.	2008-02-25
K073703	AMS MINIARC SLING SYSTEM	American Medical Systems, Inc.	2008-01-30
K071902	AMS MINIARC SLING SYSTEM	American Medical Systems, Inc.	2007-08-24
K070065	AMS SINGLE INCISION SLING SYSTEM (SIS-0)	American Medical Systems, Inc.	2007-03-01
K063136	NEEDLELESS SLING	Specialities Remeex International, S.L.	2006-12-19
K052401	GYNECARE TVT SECUR SYSTEM	ETHICON, Inc.	2005-11-28
K023898	GYNE IDEAS MINITAPE RP DEVICE	Gyne Ideas , Ltd.	2003-06-18
K020652	HERNIAMESH T-SLING	Herniamesh	2002-05-15

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08437007606058	Needleless Sling	DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL	2020-10-19
00890594000957	Desara One	Caldera Medical, Inc.	2020-02-25
00890594000971	Desara One	Caldera Medical, Inc.	2020-02-25
08714729961901	Solyx™ Blue	BOSTON SCIENTIFIC CORPORATION	2018-06-13
28032919892120	T-SLING	HERNIAMESH SRL	2016-08-05
00814723020036	MiniArc	ENDO PHARMACEUTICALS INC.	2015-10-24
00814723020104	MiniArc	ENDO PHARMACEUTICALS INC.	2015-10-24
00814723020364	MiniArc	ENDO PHARMACEUTICALS INC.	2015-10-24
05708932467407	Altis	Coloplast A/S	2015-10-22
08714729774044	Solyx™ SIS System	BOSTON SCIENTIFIC CORPORATION	2015-09-24
08714729784784	Solyx™ SIS System	BOSTON SCIENTIFIC CORPORATION	2015-09-24

Product code PAH

Related 510(k) Records#

Related GUDID Devices#