FDA product code OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
OTN is the FDA product code for mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 65 510(k) submissions under OTN, 3 in the last five years, from 28 different applicants. The average 510(k) review took 82 days (median 67). FDA has posted 1 recall for OTN devices.
Definition
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OTN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 159 |
| 2019 | 1 | 86 |
| 2020 | 1 | 87 |
| 2021 | 3 | 105 |
| 2022 | 2 | 40 |
| 2023 | 1 | 30 |
Compare with all 510(k) review times · Search every OTN clearance
Top OTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 13 | 2013-11-20 |
| Caldera Medical, Inc. | 7 | 2021-11-10 |
| ETHICON, Inc. | 6 | 2020-09-17 |
| Urocure, LLC | 3 | 2022-09-21 |
| Island Biosurgical, Inc. | 3 | 1998-09-08 |
23 more applicants have OTN clearances. See the full list in Caduvo.
Most recent OTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231549 | Boston Scientific Corporation | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | 2023-06-29 | 30 |
| K222293 | Urocure, LLC | ArcSP Suprapubic Sling System | 2022-09-21 | 51 |
| K222468 | Urocure, LLC | ArcTO Transobturator Sling System | 2022-09-15 | 30 |
| K211975 | Caldera Medical, Inc. | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | 2021-11-10 | 138 |
| K211223 | Boston Scientific Corporation | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | 2021-07-21 | 89 |
Recalls for OTN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-10-15.
Frequently asked questions
What is FDA product code OTN?
OTN is the FDA product code for mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel.
What device class is OTN?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTN?
Across 65 cleared submissions the average was 82 days from receipt to decision (median 67).
Which companies have the most OTN clearances?
American Medical Systems, Inc. (13); Caldera Medical, Inc. (7); ETHICON, Inc. (6); Urocure, LLC (3); Island Biosurgical, Inc. (3).
Have OTN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-10-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OTN
- Run a recall and safety report across every OTN manufacturer
- Watch product code OTN 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 Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times