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Ascend

FDA 510(k)

Class III (US FDA 510(k))

510(k) K083722

by Caldera Medical, Inc.

Identifiers

510(k) Number
K083722 FDA 510(k)
FDA Product Code
OTP FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 884.5980 FDA 510(k)
Regulation Number
884.5980 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ascend is a synthetic surgical mesh designed for transvaginal placement in the treatment of pelvic organ prolapse. Classified as a Class III device under FDA regulations, it is intended for use in urogynecological procedures to support pelvic organs and restore anatomical function.

This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K083722) and falls under the product code OTP, with advisory committee review by the Obstetrics/Gynecology panel. Storage and handling must comply with sterile surgical mesh protocols to ensure integrity before use.

Frequently asked questions

What is the Ascend mesh designed to treat, and how is it placed during surgery?

The Ascend is specifically designed for transvaginal placement to treat pelvic organ prolapse, a condition where pelvic organs descend into the vaginal canal. It is intended to provide support to the pelvic organs, helping to restore anatomical function during urogynecological procedures. The mesh is inserted through the vaginal route to reinforce weakened tissues and prevent further prolapse.

Is the Ascend mesh intended for single-use or can it be reused after sterilization?

The Ascend mesh is explicitly supplied sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and integrity, potentially leading to complications. Always follow sterile surgical mesh protocols to ensure proper handling and usage.

What storage and handling precautions should be taken with the Ascend mesh to maintain its integrity?

The Ascend mesh must be stored and handled according to standard sterile surgical mesh protocols to preserve its integrity before use. This includes keeping it in a sealed, sterile package until opened, protecting it from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Improper storage could compromise its performance and safety.

What regulatory pathway was followed for FDA clearance of the Ascend mesh, and which advisory committee reviewed it?

The Ascend mesh received FDA clearance through a 510(k) submission (K083722), classified as a Class III device under FDA regulations. The review was conducted under the Obstetrics/Gynecology (OB) advisory committee, which evaluates urogynecological devices like synthetic surgical meshes for pelvic organ prolapse. The clearance was granted under the product code OTP and determined to be *substantially equivalent* to a predicate 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: Caldera Medical Announces FDA Clearance of Novel Treatment for Pelvic Organ Prolapse - BioSpace, Caldera Medical - Overview, News & Similar companies | ZoomInfo.com, Caldera Medical Inc FDA Filings, Caldera Medical: Improving the Quality of Life for Women

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) K083722 24 fields · synced Sep 18, 2026