FDA product code OTP: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
OTP is the FDA product code for mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed. It is a Class III device, regulated under 21 CFR 884.5980 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 31 510(k) submissions under OTP, from 14 different applicants. The average 510(k) review took 90 days (median 69).
Definition
Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Device class | Class III |
| Regulation | 21 CFR 884.5980 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every OTP clearance
Top OTP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 9 | 2011-10-25 |
| American Medical Systems | 4 | 2012-07-20 |
| Boston Scientific Corp | 3 | 2011-09-14 |
| C.R. Bard, Inc. | 3 | 2009-01-15 |
| ETHICON, Inc. | 2 | 2008-05-15 |
9 more applicants have OTP clearances. See the full list in Caduvo.
Most recent OTP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122459 | Boston Scientific Corporation | PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM | 2012-12-13 | 122 |
| K121612 | American Medical Systems | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | 2012-07-20 | 49 |
| K112842 | American Medical Systems, Inc. | AMS ELEVATE PC | 2011-10-25 | 26 |
| K103426 | Boston Scientific Corp | LITE PELVIC FLOOR REPAIR KITS | 2011-09-14 | 296 |
| K112386 | Coloplast Corp. | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | 2011-09-08 | 21 |
Recalls for OTP devices
openFDA lists no recalls for product code OTP.
Frequently asked questions
What is FDA product code OTP?
OTP is the FDA product code for mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed. It is a Class III device, regulated under 21 CFR 884.5980 and reviewed by the Obstetrics and Gynecology panel.
What device class is OTP?
Class III, regulation 21 CFR 884.5980. Typical premarket route: PMA.
How long does a 510(k) take for product code OTP?
Across 31 cleared submissions the average was 90 days from receipt to decision (median 69).
Which companies have the most OTP clearances?
American Medical Systems, Inc. (9); American Medical Systems (4); Boston Scientific Corp (3); C.R. Bard, Inc. (3); ETHICON, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OTP
- Run a recall and safety report across every OTP manufacturer
- Watch product code OTP 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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