AdVance XP Male Sling

Q: What is the product code of K182169?

The FDA product code is OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K182169 · Boston Scientific Corporation

Substantially Equivalent

510(k) numberK182169

Submission

Device name: AdVance XP Male Sling
Applicant: Boston Scientific Corporation
Minnetonka, MN, US
Received: August 10, 2018
Decision date: November 27, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

surgical treatment of male stress urinary incontinence post-prostatectomy

Other 510(k)s with product code OTM

510(k)	Device	Applicant	Decision
K242960	AdVance XP Male Sling System (720163-03)OTM · Traditional	Boston Scientific Corporation	11/15/2024SE
K231891	Virtue Male Sling System with Alexis Wound Retractor Convenience KitOTM · Traditional	Coloplast	09/25/2023SESK
K211847	AdVance XP Male Sling SystemOTM · Traditional	Boston Scientific Corporation	12/20/2021SE
K113496	Virture Male Sling System with Alexis Wound Retractor Convenience KitOTM · Traditional	Coloplast A/S	02/14/2012SE
K111881	Virtue Male Sling System and Alexis(R) Wound Retractor KitOTM · Traditional	Coloplast A/S	08/17/2011SE
K101297	Virtue Ventral Urethral Elevation Sling System Model 50020OTM · Special	Coloplast A/S	06/03/2010SE
K091152	Virtue Ventral Urethral Elevation Sling System, Model 50020OTM · Special	Coloplast A/S	05/07/2009SE
K082640	Virtue Ventral Urethral Elevation Sling SystemOTM · Traditional	Coloplast Manufacturing Us, LLC	10/17/2008SE
K063079	I-Stop Trans Obturator Male SlingOTM · Traditional	Cl Medical	11/07/2006SE
K062341	Male Remeex SystemOTM · Traditional	Specialities Remeex International, S.L.	11/02/2006SE

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Questions and answers

When was AdVance XP Male Sling cleared by the FDA?

AdVance XP Male Sling (K182169) received a 510(k) decision of Substantially Equivalent on November 27, 2018, 109 days after the submission was received.

What is the product code of K182169?

The FDA product code is OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male, a Class II (moderate risk) device regulated under 21 CFR 878.3300.