Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
The Mesh, Surgical, Synthetic, Urogynecologic, for Apical Vaginal and Uterine Prolapse, Transabdominally Placed (product code OTO) is an implantable synthetic mesh used as bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum. It is used in procedures such as abdominal sacrocolpopexy and laparoscopic sacrocolpopexy for the repair of apical vaginal or uterine prolapse. As an FDA Class 2 device under regulation 878.3300, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty, reviewed by the Obstetrics/Gynecology panel. The device is flagged as an implant and is not life-sustaining.
Basic Information
- Product Code
- OTO
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K171271 | Polyform Synthetic Mesh | Dec 15, 2017 | Substantially Equivalent | Boston Scientific Corporation |
| K150023 | Vertessa Lite Y-Mesh | Apr 06, 2015 | Substantially Equivalent | CALDERA MEDICAL, INC. |
| K150016 | Vertessa Lite | Apr 06, 2015 | Substantially Equivalent | CALDERA MEDICAL, INC. |
| K140116 | RESTORELLE Y CONTOUR MESH | Feb 12, 2014 | Substantially Equivalent | COLOPLAST A/S |
| K132061 | RESTORELLE M, RESTORELLE XL | Aug 02, 2013 | Substantially Equivalent | COLOPLAST CORP. |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Apr 25, 2013 | Substantially Equivalent | CALDERA MEDICAL, INC. |
| K123914 | RESTORELLE Y CONTOUR | Mar 05, 2013 | Substantially Equivalent | COLOPLAST A/S |
| K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | Feb 21, 2013 | Substantially Equivalent | CALDERA MEDICAL |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | Dec 18, 2012 | Substantially Equivalent | COLOPLAST CORP. |
| K122794 | UPSYLON Y MESH | Dec 18, 2012 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K122440 | RESTORELLE L | Nov 19, 2012 | Substantially Equivalent | COLOPLAST CORP. |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | Oct 16, 2012 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS |
| K113205 | ARTISYN Y-SHAPED MESH | Jun 11, 2012 | Substantially Equivalent | ETHICON, INC. |
| K112322 | RESTORELLE POLYPROPYLENE Y MESH | May 17, 2012 | Substantially Equivalent | COLOPLAST A/S |
| K120327 | VERTESSA | May 10, 2012 | Substantially Equivalent | CALDERA MEDICAL, INC. |
| K101722 | ALYTE Y-MESH GRAFT | Apr 01, 2011 | Substantially Equivalent | C.R. BARD, INC. |
| K090739 | BARD SACROCOLPOPEXY GRAFT | Nov 10, 2009 | Substantially Equivalent | C.R. BARD, INC. |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | Feb 06, 2006 | Substantially Equivalent | MPATHY MEDICAL DEVICES, LTD. |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | Aug 03, 2005 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K051245 | POLYFORM SYNTHETIC MESH | Jun 17, 2005 | Substantially Equivalent | PROXY BIOMEDICAL LTD. |
| K041632 | MINIMESH POLYPROPYLENE MESH | Nov 17, 2004 | Substantially Equivalent | MPATHY MEDICAL DEVICES, LTD. |
| K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR | Jan 08, 2002 | Substantially Equivalent | GYNECARE, A DIV. OF ETHICON, INC. |
| K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 | Apr 09, 2001 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.