510(k) K140116

RESTORELLE Y CONTOUR MESH by Coloplast A/S — Product Code OTO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 12, 2014
Date Received: January 16, 2014
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class: Class II
Regulation Number: 878.3300
Review Panel: OB
Submission Type

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

Other clearances by Coloplast A/S

K252140 — Heylo System (October 6, 2025)
K251116 — Luja Coudé (June 27, 2025)
K250270 — Luja Set (April 17, 2025)
K242049 — SureCath Set (November 26, 2024)
K241210 — Luja Coude (November 21, 2024)
K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, (November 12, 2024)
K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (2005 (July 26, 2024)
K233411 — Folysil Silicone Catheter (April 15, 2024)
K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - (March 22, 2024)

Other clearances for product code OTO

K171271 — Polyform Synthetic Mesh (December 15, 2017)
K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
K150016 — Vertessa Lite (April 6, 2015)
K132061 — RESTORELLE M, RESTORELLE XL (August 2, 2013)
K123028 — VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (April 25, 2013)
K123914 — RESTORELLE Y CONTOUR (March 5, 2013)
K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (February 21, 2013)
K122794 — UPSYLON Y MESH (December 18, 2012)
K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)
K122440 — RESTORELLE L (November 19, 2012)