510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013718Substantially Equivalent

Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair

Gynecare, A Div. of Ethicon, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013718 is the FDA 510(k) clearance record for GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR, a class II device, cleared for Gynecare, A Div. of Ethicon, Inc. on under FDA product code OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed). FDA's definition for product code OTO reads: "Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy". FDA records list 2 510(k) clearances for Gynecare, A Div. of Ethicon, Inc., from to . As of , FDA records show one recall naming K013718.

Clearance record

Decision date
Received
(61 days to decision)
Product code
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gynecare, A Div. of Ethicon, Inc. P.O. Box 151, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code OTO

Trailing 12 months

FDA records hold no clearances under product code OTO in the trailing twelve months.

FDA records show no clearances under product code OTO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OTO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260