Kerecis Reconstruct
by Kerecis Limited Iceland 510(k)
510(k) K202430
Product code OXH
Overview
Kerecis Reconstruct is a surgical mesh device derived from Atlantic cod skin, classified as a collagen-based implant for plastic and reconstructive surgery. It is designed to provide physical reinforcement of soft tissue defects or weaknesses, offering a resorbable and biocompatible solution for wound management.
The device is supplied as a single-use, non-crosslinked implant intended for use in plastic surgery procedures. It is regulated under FDA 510(k) clearance (K202430) and falls under the classification of Mesh, Surgical, Collagen, with a product code of OXH. Sterility and handling instructions are manufacturer-specific, but it is intended for sterile application in controlled surgical environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202430 | Date2 May 2021 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kerecis Limited
Questions
What types of surgical procedures is the Kerecis Reconstruct mesh intended for, and why is it considered suitable for these applications?
The Kerecis Reconstruct is designed for plastic and reconstructive surgery procedures where soft tissue reinforcement is needed, such as repairing defects or weaknesses in soft tissue. It is derived from Atlantic cod skin and is classified as a collagen-based implant, offering a resorbable and biocompatible solution. This makes it particularly useful for applications requiring temporary structural support that will eventually integrate with the body’s natural tissue.
Is the Kerecis Reconstruct mesh intended for single-use only, and how should it be handled to maintain sterility?
Yes, the Kerecis Reconstruct mesh is explicitly supplied as a single-use device. Since it is intended for sterile application in controlled surgical environments, it must be handled according to the manufacturer’s specific sterility and handling instructions to ensure it remains uncontaminated before use.
What regulatory pathway was followed for the FDA clearance of the Kerecis Reconstruct, and what does this mean for its use in clinical settings?
The Kerecis Reconstruct received FDA clearance through a 510(k) submission, specifically under the classification of *Mesh, Surgical, Collagen* with product code OXH. The clearance was granted as *Substantially Equivalent* (SESE) to a predicate device, meaning it was determined to have the same intended use and technological characteristics as an already-approved device. This pathway ensures the device meets regulatory standards for safety and effectiveness in its designated surgical applications.
How is the Kerecis Reconstruct mesh supplied, and are there different sizes or models available?
The Kerecis Reconstruct is supplied as a single-use, non-crosslinked implant, but the provided data does not specify exact sizes or models. However, the device is categorized under *Mesh, Surgical, Collagen* with multiple registration numbers, suggesting it may come in various configurations to accommodate different surgical needs. For precise sizing options, refer to the manufacturer’s product documentation.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K202430