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Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System,…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211975

by Caldera Medical, Inc.

Identifiers

510(k) Number
K211975 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 TV EZ and Desara Blue TV EZ systems are synthetic, urogynecologic surgical mesh devices. They are intended for use in females to position a mesh for the treatment of genuine stress urinary incontinence, including mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

These systems are designed for a transvaginal approach and include features such as a blue dilator tube to assist with visualization during cystoscopy and a thermally bonded sleeve for smooth tissue passage. The devices are subject to FDA 510(k) clearance under K211975. Availability and specific storage requirements may vary by region, and users should consult with their distributor for local product details.

Frequently asked questions

What is the intended use of the Desara TV EZ systems?

These synthetic urogynecologic surgical mesh devices are intended for use in females to treat genuine stress urinary incontinence, including mixed incontinence cases caused by urethral hypermobility or intrinsic sphincter deficiency.

What are the key design features of these mesh systems?

The systems are designed for a transvaginal approach and include a thermally bonded sleeve to facilitate smooth tissue passage, as well as a blue dilator tube specifically included to assist with visualization during cystoscopy.

What regulatory authorization does this device hold?

The Desara TV EZ and Desara Blue TV EZ systems have received FDA 510(k) clearance under K211975, confirming they are substantially equivalent to predicate devices.

How can I obtain specific storage and availability information?

Because availability and specific storage requirements for these devices may vary by region, users should contact their local distributor to obtain precise product details and handling instructions.

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 TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 ..., Desara TV Family - Caldera Medical, Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA 510(k) K211975 24 fields · synced Oct 6, 2026