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Alexis O Wound Protector/Retractor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113268

by Applied Medical Resources Corp.

Identifiers

510(k) Number
K113268 FDA 510(k)
FDA Product Code
KGW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Alexis O Wound Protector/Retractor is an internal ring‑type wound protector and drape retention device that provides 360‑degree circumferential retraction of the incision site. It is designed to maintain moisture at the surgical wound and to facilitate exposure of the operative field during procedures such as colorectal surgery.

The device is cleared under FDA 510(k) traditional review (K113268) as a Class II medical device for general and plastic surgery applications. It is supplied sterile, intended for single‑use intra‑operative use, and is available in multiple sizes, including an X‑Large configuration (Manufacturer Part # C8404) with a rigid outer ring for maximal exposure.

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: Alexis O Wound Protector/Retractor | Applied Medical, Alexis Protectors and Systems - Applied Medical, Applied Medical Alexis O Wound Protector / Retractor - ALEXIS O ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA 510(k) K113268 24 fields · synced Sep 25, 2026