FDA.report

510(k) K242473

Device
Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
Applicant
Coloplast Corp.
510(k) number
K242473
Product code
PAH
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-18
Date received
2024-08-20
Regulation
878.3300
Classification name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jennifer Mrkvicka
Address
1601 W. River Rd. N. Plymouth MN US 55411 55411

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PAH

510(k)DeviceApplicantDecision date
K221874Altis Single Incision Sling SystemColoplast A/S2023-02-15
K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc.2020-02-07
K121562ALTIS SINGLE INCISION CLING SYSTEMColoplast A/S2012-11-05
K123179AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLINGC.R. Bard, Inc.2012-11-02
K121641MINIARC PRO SINGLE-INCISION SLING SYSTEMAmerican Medical Systems2012-09-07
K110420OPHIRA MINI SLING SYSTEMPromedon S.A2012-05-08
K103418DESARA MINICaldera Medical, Inc.2011-11-30
K100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191American Medical Systems, Inc.2010-06-07
K092607AJUST ADJUSTABLE SINGLE INCISION SLINGC.R. Bard, Inc.2009-11-20
K091180MINITAPE URETHRAL SLINGMpathy Medical Devices, Ltd.2009-07-14
K081275BOSTON SCIENTIFIC SURGICAL MESHBoston Scientific Corp2008-08-27
K073646MINITAPE URETHRAL SLINGMpathy Medical Devices, Ltd.2008-02-25
K073703AMS MINIARC SLING SYSTEMAmerican Medical Systems, Inc.2008-01-30
K071902AMS MINIARC SLING SYSTEMAmerican Medical Systems, Inc.2007-08-24
K070065AMS SINGLE INCISION SLING SYSTEM (SIS-0)American Medical Systems, Inc.2007-03-01