Virtue Ventral Urethral Elevation Sling System Model 50020

Q: What is the product code of K101297?

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) K101297 · Coloplast A/S

Substantially Equivalent

510(k) numberK101297

Submission

Device name: Virtue Ventral Urethral Elevation Sling System Model 50020
Applicant: Coloplast A/S
Plymouth, MN, US
Received: May 10, 2010
Decision date: June 3, 2010
Decision: Substantially Equivalent (SESE)
Type: Special 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

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K211847	AdVance XP Male Sling SystemOTM · Traditional	Boston Scientific Corporation	12/20/2021SE
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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
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 Virtue Ventral Urethral Elevation Sling System Model 50020 cleared by the FDA?

Virtue Ventral Urethral Elevation Sling System Model 50020 (K101297) received a 510(k) decision of Substantially Equivalent on June 3, 2010, 24 days after the submission was received.

What is the product code of K101297?

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.