Exair Anterior and Posterior Prolapse Repair System
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K112386 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 Exair Anterior and Posterior Prolapse Repair System is a synthetic surgical mesh device designed for transvaginal placement in the repair of pelvic organ prolapse. Classified as a Class III device under FDA regulations, it is intended for use in urogynecological procedures to support and reinforce weakened pelvic tissues.
This system is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K112386) and falls under the product code OTP, with advisory committee review by the Obstetrics/Gynecology panel. Storage and handling must comply with standard surgical mesh protocols to maintain sterility and integrity prior to use.
Frequently asked questions
What types of pelvic organ prolapse procedures is this mesh system designed for?
The Exair Anterior and Posterior Prolapse Repair System is specifically designed for transvaginal placement to support and reinforce weakened pelvic tissues in urogynecological procedures. It is intended for repairing both anterior and posterior pelvic organ prolapse, where the mesh provides structural reinforcement to restore anatomical integrity.
Is this mesh system reusable, or is it meant for single-use only?
This system is explicitly labeled for single-use only. It is supplied sterile and must not be reused to ensure patient safety and maintain sterility, as per standard surgical mesh protocols.
How should I store this device before use to keep it in good condition?
The Exair Anterior and Posterior Prolapse Repair System must be stored and handled according to standard surgical mesh protocols to preserve sterility and structural integrity. Follow manufacturer guidelines to avoid exposure to moisture, contamination, or physical damage prior to use.
What regulatory pathway was followed for FDA clearance of this device?
The Exair Anterior and Posterior Prolapse Repair System underwent FDA review through a 510(k) clearance process (K112386) with a Special clearance type, determined to be *substantially equivalent* to a predicate device. It was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and falls under product code OTP for transvaginal surgical mesh.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112386 | Class III | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA 510(k) K112386 24 fields · synced Sep 18, 2026