Minimesh Polypropylene Mesh

Q: What is the product code of K041632?

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) K041632 · Mpathy Medical Devices, Ltd.

Substantially Equivalent

510(k) numberK041632

Submission

Device name: Minimesh Polypropylene Mesh
Applicant: Mpathy Medical Devices, Ltd.
Farfield, CT, US
Received: June 16, 2004
Decision date: November 17, 2004
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

More from Boston Scientific Corp

510(k)	Device	Decision
K092203	Omnisure Urethral Sling, Model OTK52OTN · Special	08/12/2009SE
K092207	Restorelle Polypropylene MeshOTP · Special	08/04/2009SE
K091180	Minitape Urethral SlingPAH · Special	07/14/2009SE
K073647	Minitape Extra Urethral SlingOTN · Special	03/03/2008SE
K073646	Minitape Urethral SlingPAH · Special	02/25/2008SE
K053361	Modification to: Minimesh Polypropylene MeshOTO · Special	02/06/2006SE

Questions and answers

When was Minimesh Polypropylene Mesh cleared by the FDA?

Minimesh Polypropylene Mesh (K041632) received a 510(k) decision of Substantially Equivalent on November 17, 2004, 154 days after the submission was received.

What is the product code of K041632?

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.