Coloplast 52081

• FDA 510(k) K140116 decided 12 Feb 2014 Active
• FDA GUDID UDI-DI 05708932553773 listed 22 Oct 2015 Listed

1. 12 Feb 2014 Cleared FDA 510(k) K140116
2. 22 Oct 2015 Listed FDA GUDID 05708932553773

Trade name

Coloplast

Generic name

Pelvic organ prolapse surgical mesh, synthetic polymer

Model / Ref / Catalog

52081

Primary DI / UDI-DI

05708932553773

510(k) Number

K140116 ↗

FDA product code

OTO

GMDN term

Pelvic organ prolapse surgical mesh, synthetic polymer

Device class

Class II

Regulation number

878.3300

GUDID distribution status

In Commercial Distribution

Size

Length — 24 Centimeter

Width — 3 Centimeter

Category: Pelvic organ prolapse surgical mesh, synthetic polymer

Other devices filed under FDA product code OTO (Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed).

• BARD SACROCOLPOPEXY GRAFT by C. R. Bard, Inc.
• AMS PELVIC FLOOR REPAIR SYSTEM by AMERICAN MEDICAL SYSTEMS, INC.
• Vertessa Lite by CALDERA MEDICAL, INC.
• ARTISYN Y-SHAPED MESH by Ethicon Inc.
• ALYTE Y-MESH GRAFT by C. R. Bard, Inc.
• Vertessa Lite Y-Mesh by CALDERA MEDICAL, INC.
• Minimesh Polypropylene Mesh by Mpathy Medical Devices, Ltd.
• Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015 by Coloplast Corp.
• Polyform Synthetic Mesh by Boston Scientific

• Peristeen Plus

  Class I

  CE/MDR

• SenSura

  Class I

  CE/MDR

• Alterna

  Class I

  CE/MDR

• SenSura Mio Convex

  Class I

  CE/MDR

See all devices from Coloplast A/S →