Restorelle Polypropylene Y Mesh

Q: What is the product code of K112322?

The FDA product code is OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K112322 · Coloplast A/S

Substantially Equivalent

510(k) numberK112322

Submission

Device name: Restorelle Polypropylene Y Mesh
Applicant: Coloplast A/S
Plymouth, MN, US
Received: August 12, 2011
Decision date: May 17, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

Other 510(k)s with product code OTO

510(k)	Device	Applicant	Decision
K171271	Polyform Synthetic MeshOTO · Special	Boston Scientific Corporation	12/15/2017SE
K150023	Vertessa Lite Y-MeshOTO · Traditional	Caldera Medical, Inc.	04/06/2015SE
K150016	Vertessa LiteOTO · Traditional	Caldera Medical, Inc.	04/06/2015SE
K140116	Restorelle Y Contour MeshOTO · Special	Coloplast A/S	02/12/2014SE
K132061	Restorelle M, Restorelle XLOTO · Special	Coloplast Corp.	08/02/2013SE
K123028	Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshOTO · Traditional	Caldera Medical, Inc.	04/25/2013SE
K123914	Restorelle Y ContourOTO · Special	Coloplast A/S	03/05/2013SE
K123337	Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMOTO · Traditional	Caldera Medical	02/21/2013SE
K122968	Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015OTO · Traditional	Coloplast Corp.	12/18/2012SE
K122794	Upsylon Y MeshOTO · Traditional	Boston Scientific Corp	12/18/2012SE

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Questions and answers

When was Restorelle Polypropylene Y Mesh cleared by the FDA?

Restorelle Polypropylene Y Mesh (K112322) received a 510(k) decision of Substantially Equivalent on May 17, 2012, 279 days after the submission was received.

What is the product code of K112322?

The FDA product code is OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a Class II (moderate risk) device regulated under 21 CFR 878.3300.