Bard Sacrocolpopexy Graft

Q: What is the product code of K090739?

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) K090739 · C.R. Bard, Inc.

Substantially Equivalent

510(k) numberK090739

Submission

Device name: Bard Sacrocolpopexy Graft
Applicant: C.R. Bard, Inc.
Covington, GA, US
Received: March 20, 2009
Decision date: November 10, 2009
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.

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K171271	Polyform Synthetic MeshOTO · Special	Boston Scientific Corporation	12/15/2017SE
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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 Bard Sacrocolpopexy Graft cleared by the FDA?

Bard Sacrocolpopexy Graft (K090739) received a 510(k) decision of Substantially Equivalent on November 10, 2009, 235 days after the submission was received.

What is the product code of K090739?

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.