FDA.reportPublic FDA data

510(k) K221874

Device
Altis Single Incision Sling System
Applicant
Coloplast A/S
510(k) number
K221874
Product code
PAH
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-15
Date received
2022-06-28
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gayatri Ghadge
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), Device, Applicant table
510(k)DeviceApplicantDecision date
K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp.2024-10-18
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