The following data is part of a premarket notification filed by Gynecare, A Div. Of Ethicon, Inc. with the FDA for Gynemesh Prolene Soft (polypropylene) Nonabsorbable Synthetic Surgical Mesh For Pelvic Floor Repair.
| Device ID | K013718 |
| 510k Number | K013718 |
| Device Name: | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | GYNECARE, A DIV. OF ETHICON, INC. P.O. BOX 151 Somerville, NJ 08876 |
| Contact | Gregory R Jones |
| Correspondent | Gregory R Jones GYNECARE, A DIV. OF ETHICON, INC. P.O. BOX 151 Somerville, NJ 08876 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-08 |
| Decision Date | 2002-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031037738 | K013718 | 000 |
| 10705031037748 | K013718 | 000 |
| 10705031037731 | K013718 | 000 |