FDA product code OTM: Mesh, Surgical, For Stress Urinary Incontinence, Male
OTM is the FDA product code for mesh, surgical, for stress urinary incontinence, male. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under OTM, 2 in the last five years, from 7 different applicants. The average 510(k) review took 68 days (median 56); 51 days on average over the last three years. FDA has posted 1 recall for OTM devices.
Definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| 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 OTM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 109 |
| 2021 | 1 | 188 |
| 2023 | 1 | 90 |
| 2024 | 1 | 51 |
Compare with all 510(k) review times · Search every OTM clearance
Top OTM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast A/S | 4 | 2012-02-14 |
| Boston Scientific Corporation | 3 | 2024-11-15 |
| Coloplast | 1 | 2023-09-25 |
| Coloplast Manufacturing Us, LLC | 1 | 2008-10-17 |
| Cl Medical | 1 | 2006-11-07 |
2 more applicants have OTM clearances. See the full list in Caduvo.
Most recent OTM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242960 | Boston Scientific Corporation | AdVance XP Male Sling System (720163-03) | 2024-11-15 | 51 |
| K231891 | Coloplast | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | 2023-09-25 | 90 |
| K211847 | Boston Scientific Corporation | AdVance XP Male Sling System | 2021-12-20 | 188 |
| K182169 | Boston Scientific Corporation | AdVance XP Male Sling | 2018-11-27 | 109 |
| K113496 | Coloplast A/S | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT | 2012-02-14 | 81 |
Recalls for OTM 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 OTM?
OTM is the FDA product code for mesh, surgical, for stress urinary incontinence, male. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel.
What device class is OTM?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTM?
Across 12 cleared submissions the average was 68 days from receipt to decision (median 56).
Which companies have the most OTM clearances?
Coloplast A/S (4); Boston Scientific Corporation (3); Coloplast (1); Coloplast Manufacturing Us, LLC (1); Cl Medical (1).
Have OTM 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 OTM
- Run a recall and safety report across every OTM manufacturer
- Watch product code OTM 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.
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