Mentor Obtape Trans-Obturator Tape
FDA 510(k) K031767 · Mentor Corp.
510(k) numberK031767
Submission
- Device name
- Mentor Obtape Trans-Obturator Tape
- Applicant
- Mentor Corp.
Santa Barbara, CA, US - Received
- June 9, 2003
- Decision date
- July 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
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| K222293 | ArcSP Suprapubic Sling SystemOTN · Special | Urocure, LLC | 09/21/2022SE |
| K222468 | ArcTO Transobturator Sling SystemOTN · Special | Urocure, LLC | 09/15/2022SE |
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| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Traditional | Boston Scientific Corporation | 07/21/2021SE |
| K210087 | Athena Surgical RMUS SystemOTN · Traditional | Athena Surgical, LLC | 04/12/2021SE |
| K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT…OTN · Traditional | ETHICON, Inc. | 09/17/2020SE |
| K183134 | ArcTV Transvaginal Sling SystemOTN · Traditional | Urocure, LLC | 02/07/2019SE |
| K162201 | Desara TV, Desara Blue TVOTN · Traditional | Caldera Medical, Inc. | 01/11/2017SE |
| K140843 | Desara Blue Ov, Desara Blue SSOTN · Special | Caldera Medical | 07/01/2014SE |
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| 510(k) | Device | Decision |
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| K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…LCJ · Special | 04/11/2013SE |
| K062421 | Mentor Resterilizable Gel Breast Implant SizerMRD · Traditional | 10/10/2006SE |
| K053414 | Mentor Novasilk MeshOTP · Traditional | 12/27/2005SE |
| K053296 | Mentor Aris Suprapubic Surgical KitOTN · Traditional | 12/15/2005SE |
| K052440 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Special | 10/11/2005SE |
| K050008 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Traditional | 06/03/2005SE |
| K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitOTN · Traditional | 03/09/2005SE |
| K042851 | Mentor Obtape Trans-Obturator Surgical KitOTN · Special | 11/09/2004SE |
| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | 10/29/2004SE |
| K011493 | Mentor Isoloader Automatic Needle Loading System and Physics Workstation for BrachytherapyKPT · Traditional | 10/01/2002SE |
Questions and answers
When was Mentor Obtape Trans-Obturator Tape cleared by the FDA?
Mentor Obtape Trans-Obturator Tape (K031767) received a 510(k) decision of Substantially Equivalent on July 17, 2003, 38 days after the submission was received.
What is the product code of K031767?
The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.