Desara Blue Ov, Desara Blue SS
FDA 510(k) K140843 · Caldera Medical
510(k) numberK140843
Submission
- Device name
- Desara Blue Ov, Desara Blue SS
- Applicant
- Caldera Medical
Agoura Hills, CA, US - Received
- April 2, 2014
- Decision date
- July 1, 2014
- 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 |
| K131229 | Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special | American Medical Systems | 12/05/2013SE |
More from American Medical Systems
| 510(k) | Device | Decision |
|---|---|---|
| K233500 | Benesta Tissue Removal DeviceHIH · Special | 11/30/2023SE |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…OTN · Special | 11/10/2021SE |
| K192811 | BenestaTM Tissue Removal DeviceHIH · Traditional | 10/23/2020SE |
| K192822 | Benesta HysteroscopeHIH · Traditional | 09/09/2020SE |
| K193603 | Benesta Medical Sterilization TrayKCT · Traditional | 07/20/2020SE |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling…PAH · Traditional | 02/07/2020SE |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator…PWJ · Traditional | 05/04/2018SE |
| K162201 | Desara TV, Desara Blue TVOTN · Traditional | 01/11/2017SE |
| K150023 | Vertessa Lite Y-MeshOTO · Traditional | 04/06/2015SE |
| K150016 | Vertessa LiteOTO · Traditional | 04/06/2015SE |
Questions and answers
When was Desara Blue Ov, Desara Blue SS cleared by the FDA?
Desara Blue Ov, Desara Blue SS (K140843) received a 510(k) decision of Substantially Equivalent on July 1, 2014, 90 days after the submission was received.
What is the product code of K140843?
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.