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CP-FIBER (OrthoFiber)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K094028

by Cp Medical

Identifiers

510(k) Number
K094028 FDA 510(k)
FDA Product Code
GAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5000 FDA 510(k)
Regulation Number
878.5000 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CP-FIBER (OrthoFiber) is a synthetic non-absorbable suture composed of a braided polyblend. It is classified as a non-absorbable suture, synthetic, polyethylene under product code GAT. The device is intended for use in general and plastic surgery procedures.

CP-FIBER (OrthoFiber) is supplied as a Class II device under regulation 21 CFR 878.5000. It has FDA 510(k) clearance with number K094028, received on 2009-12-30 and decided as substantially equivalent on 2010-03-18. The device is manufactured by CP Medical, Inc. in Portland, OR.

Frequently asked questions

What is CP-FIBER (OrthoFiber) used for?

CP-FIBER (OrthoFiber) is a synthetic non-absorbable suture composed of a braided polyblend, intended for use in general and plastic surgery procedures. It provides durable support in tissues where permanent wound support is required.

How is CP-FIBER (OrthoFiber) supplied?

CP-FIBER (OrthoFiber) is supplied as a Class II medical device under regulation 21 CFR 878.5000. It is manufactured by CP Medical, Inc. in Portland, OR, and is available in various sizes and lengths suitable for different surgical applications.

Is CP-FIBER (OrthoFiber) sterile and single-use?

The device data does not specify sterility status or single-use/reuse information. As a surgical suture, it is typically supplied sterile for single-use procedures to minimize infection risk, but specific handling instructions would be provided in the product documentation.

What regulatory approvals does CP-FIBER (OrthoFiber) have?

CP-FIBER (OrthoFiber) has FDA 510(k) clearance with number K094028, received on 2009-12-30 and decided as substantially equivalent on 2010-03-18. It is classified under product code GAT as a non-absorbable suture, synthetic, polyethylene.

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: CP-FIBER (ORTHOFIBER) (K094028) — FDA 510 (k) | Innolitics, PDF tPortlndOR USA - Food and Drug Administration, CP-FIBER (ORTHOFIBER) 510 (k) K094028 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cp Medical

Sources (1)

  • FDA 510(k) K094028 24 fields · synced Sep 26, 2026