Minitape Extra Urethral Sling
FDA 510(k) K073647 · Mpathy Medical Devices, Ltd.
510(k) numberK073647
Submission
- Device name
- Minitape Extra Urethral Sling
- Applicant
- Mpathy Medical Devices, Ltd.
Madison, CT, US - Received
- December 26, 2007
- Decision date
- March 3, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code OTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Special | Boston Scientific Corporation | 06/29/2023SE |
| K222293 | ArcSP Suprapubic Sling SystemOTN · Special | Urocure, LLC | 09/21/2022SE |
| K222468 | ArcTO Transobturator Sling SystemOTN · Special | Urocure, LLC | 09/15/2022SE |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…OTN · Special | Caldera Medical, Inc. | 11/10/2021SE |
| 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 |
More from Caldera Medical
| 510(k) | Device | Decision |
|---|---|---|
| K092203 | Omnisure Urethral Sling, Model OTK52OTN · Special | 08/12/2009SE |
| K092207 | Restorelle Polypropylene MeshOTP · Special | 08/04/2009SE |
| K091180 | Minitape Urethral SlingPAH · Special | 07/14/2009SE |
| K073646 | Minitape Urethral SlingPAH · Special | 02/25/2008SE |
| K053361 | Modification to: Minimesh Polypropylene MeshOTO · Special | 02/06/2006SE |
| K041632 | Minimesh Polypropylene MeshOTO · Traditional | 11/17/2004SE |
Questions and answers
When was Minitape Extra Urethral Sling cleared by the FDA?
Minitape Extra Urethral Sling (K073647) received a 510(k) decision of Substantially Equivalent on March 3, 2008, 68 days after the submission was received.
What is the product code of K073647?
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.