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CWM-930S Fixer DV9

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233120

by Chungwoo Co., Ltd.

Identifiers

510(k) Number
K233120 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CWM-930S Fixer DV9 is an electrosurgical cutting and coagulation device accessory, designed for use in general and plastic surgery procedures. It is classified under the Product Code GEI and functions as part of an electrosurgical system to facilitate precise tissue dissection and hemostasis during surgical interventions. This device operates within the regulatory framework of Class II special controls, ensuring compliance with established safety and performance standards for electrosurgical accessories.

The CWM-930S Fixer DV9 is supplied as a reusable medical device, intended for integration with compatible electrosurgical generators. It is regulated under the Medical Device Directive (MDD) and holds an FDA 510(k) clearance (K233120) as substantially equivalent to a predicate device, with a decision date of May 23, 2024. The device is manufactured by Chungwoo Co., Ltd., and adheres to regulatory requirements for electrosurgical cutting and coagulation accessories as outlined in 21 CFR 878.4400. No specific sterility or single-use designation is stated in the available data.

Frequently asked questions

What types of surgical procedures is the CWM-930S Fixer DV9 intended to assist with, and how does it function within those procedures?

The CWM-930S Fixer DV9 is designed specifically for use in general and plastic surgery procedures. It functions as an accessory for electrosurgical systems, enabling precise tissue dissection and hemostasis—meaning it helps cut tissue cleanly while simultaneously stopping bleeding. This dual capability is particularly useful in surgeries where both cutting and sealing blood vessels are required, such as in plastic reconstructive work or other delicate procedures.

Is the CWM-930S Fixer DV9 a single-use or reusable device, and what does that mean for maintenance or replacement?

The CWM-930S Fixer DV9 is reusable, meaning it is intended for repeated use in multiple surgical procedures after proper cleaning and maintenance. Unlike single-use devices, this requires adherence to manufacturer guidelines for sterilization and care to ensure safety and performance. Reusability can reduce costs over time but also introduces the need for a robust infection control protocol to maintain sterility between uses.

How is the CWM-930S Fixer DV9 regulated, and what does its classification under Product Code GEI imply about its safety standards?

The CWM-930S Fixer DV9 is classified under Product Code GEI, which categorizes it as an electrosurgical cutting and coagulation accessory. This classification places it under Class II special controls in the regulatory framework, meaning it must meet stringent safety and performance standards to ensure proper functionality and patient safety during surgical use. The device holds both FDA 510(k) clearance (K233120) and compliance with the Medical Device Directive (MDD), confirming its adherence to established regulatory requirements.

What should clinicians consider when storing the CWM-930S Fixer DV9 to ensure its longevity and readiness for use?

Since the CWM-930S Fixer DV9 is reusable, proper storage is critical to maintain its functionality and sterility. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following the manufacturer’s guidelines for electrosurgical accessories. If not in use, it should be kept in a dedicated case or storage solution to prevent damage or contamination. Regular maintenance, including cleaning and inspection, is also essential to ensure it remains operational for repeated surgical use.

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: CWM-930S, FIXER DV9 (K233120) — FDA 510 (k) | Innolitics, CWM-930S, FIXER DV9 510 (k) K233120 - FDA.report, K233120 FDA 510 (k) - CWM-930S | Chungwoo Co., Ltd.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Chungwoo Co., Ltd.

Sources (2)

  • FDA 510(k) K233120 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026