Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
FDA 510(k) K211975 · Caldera Medical, Inc.
510(k) numberK211975
Submission
- Device name
- Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- Applicant
- Caldera Medical, Inc.
Westlake Village, CA, US - Received
- June 25, 2021
- Decision date
- November 10, 2021
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K131229 | Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special | American Medical Systems | 12/05/2013SE |
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| K233500 | Benesta Tissue Removal DeviceHIH · Special | 11/30/2023SE |
| 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 |
| K140843 | Desara Blue Ov, Desara Blue SSOTN · Special | 07/01/2014SE |
Questions and answers
When was Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System cleared by the FDA?
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System (K211975) received a 510(k) decision of Substantially Equivalent on November 10, 2021, 138 days after the submission was received.
What is the product code of K211975?
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.