Identifiers
- 510(k) Number
- K121928 FDA 510(k)
- FDA Product Code
- OTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Desara SL is a synthetic surgical mesh device classified as a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator. It is a short-length transobturator tape (TOT) sling designed for the treatment of stress urinary incontinence.
The device is supplied as a single-use implant and is compatible with all Caldera Medical TOT introducers. It has a length of 12 cm, which reduces the amount of mesh implanted compared to traditional slings. The Desara SL received FDA 510(k) clearance under K121928 and is classified as a Class II medical device.
Frequently asked questions
What is the Desara SL used for?
The Desara SL is designed for the treatment of stress urinary incontinence in female patients. It is a short-length transobturator tape (TOT) sling made of synthetic surgical mesh, implanted via retropubic or transobturator approach to support the urethra and reduce incontinence episodes.
How is the Desara SL supplied and is it reusable?
The Desara SL is supplied as a single-use implant only. It is not intended for reuse, reprocessing, or resterilization. Each device is packaged for one-time implantation to ensure sterility and patient safety, in accordance with its single-use labeling.
What is the length of the Desara SL and how does it compare to other slings?
The Desara SL has a fixed length of 12 cm, which is shorter than traditional transobturator or retropubic slings. This reduced length minimizes the amount of synthetic mesh implanted while still providing adequate urethral support for stress urinary incontinence treatment.
What introducer systems is the Desara SL compatible with?
The Desara SL is designed to be used exclusively with Caldera Medical TOT introducers. It is compatible with all Caldera Medical transobturator tape (TOT) introducer systems, ensuring proper deployment and positioning during implantation.
What regulatory pathway was used for the Desara SL?
The Desara SL received market authorization through the FDA 510(k) premarket notification process under clearance number K121928. It was found substantially equivalent to a predicate device and is classified as a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Desara SL - Caldera Medical, Desara SL - Caldera Medical, Desara - Caldera Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121928 | Class II | Active |
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Manufacturer
- Manufacturer
- Caldera Medical, Inc.
Sources (1)
- FDA 510(k) K121928 24 fields · synced Sep 21, 2026