Product Code: PAH FDA class 2 21 CFR 878.3300

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

General, Plastic Surgery

The Mesh, Surgical, Synthetic, Urogynecologic, for Stress Urinary Incontinence, Female, Mini-Sling is a synthetic surgical mesh implant used for the transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency and/or urethral hypermobility via a mini-sling approach. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAH, with regulation number 878.3300 under the General, Plastic Surgery specialty, reviewed by the gastroenterology/urology panel, and it carries an implant flag.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: PAH
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

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