FDA product code OTO: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
OTO is the FDA product code for mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 23 510(k) submissions under OTO, from 13 different applicants. The average 510(k) review took 120 days (median 97). FDA has posted 1 recall for OTO devices.
Definition
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OTO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 228 |
Compare with all 510(k) review times · Search every OTO clearance
Top OTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Caldera Medical, Inc. | 4 | 2015-04-06 |
| Coloplast A/S | 3 | 2014-02-12 |
| Coloplast Corp. | 3 | 2013-08-02 |
| C.R. Bard, Inc. | 2 | 2011-04-01 |
| Mpathy Medical Devices, Ltd. | 2 | 2006-02-06 |
8 more applicants have OTO clearances. See the full list in Caduvo.
Most recent OTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171271 | Boston Scientific Corporation | Polyform Synthetic Mesh | 2017-12-15 | 228 |
| K150016 | Caldera Medical, Inc. | Vertessa Lite | 2015-04-06 | 91 |
| K150023 | Caldera Medical, Inc. | Vertessa Lite Y-Mesh | 2015-04-06 | 90 |
| K140116 | Coloplast A/S | RESTORELLE Y CONTOUR MESH | 2014-02-12 | 27 |
| K132061 | Coloplast Corp. | RESTORELLE M, RESTORELLE XL | 2013-08-02 | 30 |
Recalls for OTO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-04-12.
Frequently asked questions
What is FDA product code OTO?
OTO is the FDA product code for mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Obstetrics and Gynecology panel.
What device class is OTO?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTO?
Across 23 cleared submissions the average was 120 days from receipt to decision (median 97).
Which companies have the most OTO clearances?
Caldera Medical, Inc. (4); Coloplast A/S (3); Coloplast Corp. (3); C.R. Bard, Inc. (2); Mpathy Medical Devices, Ltd. (2).
Have OTO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code OTO
- Run a recall and safety report across every OTO manufacturer
- Watch product code OTO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times