PAH · Class II · 21 CFR 878.3300

FDA Product Code PAH: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.

Leading manufacturers include American Medical Systems, Inc., Mpathy Medical Devices, Ltd. and C.R. Bard, Inc..

20
Total
20
Cleared
132d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling Devices (Product Code PAH)

20 devices
1–20 of 20
Cleared Oct 18, 2024
Altis Single Incision Sling System (519650)
K242473
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Feb 15, 2023
Altis Single Incision Sling System
K221874
Coloplast A/S
Gastroenterology & Urology · 232d
Cleared Feb 07, 2020
Desara One Single Incision Sling System, 1 Pack
K191416
Caldera Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 05, 2012
ALTIS SINGLE INCISION CLING SYSTEM
K121562
Coloplast A/S
Gastroenterology & Urology · 160d
Cleared Nov 02, 2012
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
K123179
C.R. Bard, Inc.
Gastroenterology & Urology · 24d
Cleared Sep 07, 2012
MINIARC PRO SINGLE-INCISION SLING SYSTEM
K121641
American Medical Systems
Gastroenterology & Urology · 95d
Cleared May 08, 2012
OPHIRA MINI SLING SYSTEM
K110420
Promedon S.A
Gastroenterology & Urology · 449d
Cleared Nov 30, 2011
DESARA MINI
K103418
Caldera Medical, Inc.
Gastroenterology & Urology · 373d
Cleared Jun 07, 2010
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
K100807
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 20, 2009
AJUST ADJUSTABLE SINGLE INCISION SLING
K092607
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 14, 2009
MINITAPE URETHRAL SLING
K091180
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 82d
Cleared Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
K081275
Boston Scientific Corp
Gastroenterology & Urology · 114d
Cleared Feb 25, 2008
MINITAPE URETHRAL SLING
K073646
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 61d
Cleared Jan 30, 2008
AMS MINIARC SLING SYSTEM
K073703
American Medical Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 24, 2007
AMS MINIARC SLING SYSTEM
K071902
American Medical Systems, Inc.
Gastroenterology & Urology · 45d
Cleared Mar 01, 2007
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
K070065
American Medical Systems, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 19, 2006
NEEDLELESS SLING
K063136
Specialities Remeex International, S.L.
Gastroenterology & Urology · 64d
Cleared Nov 28, 2005
GYNECARE TVT SECUR SYSTEM
K052401
Ethicon, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 18, 2003
GYNE IDEAS MINITAPE RP DEVICE
K023898
Gyne Ideas , Ltd.
Gastroenterology & Urology · 208d
Cleared May 15, 2002
HERNIAMESH T-SLING
K020652
Herniamesh
Gastroenterology & Urology · 76d

About Product Code PAH - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code PAH since 2002, with 20 receiving FDA clearance (average review time: 132 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.