Identifiers
- 510(k) Number
- K990443 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arthro-Surgimat-2000 ECU is an arthroscope, classified under product code HRX and intended for orthopedic surgical procedures. It is designed to facilitate visualization and irrigation within joint spaces during arthroscopic surgery, enabling precise diagnostic and therapeutic interventions.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K990443) with a classification as Special under the Orthopedic review panel. It was determined substantially equivalent to prior devices and is intended for use in controlled surgical environments, adhering to standard sterility and handling protocols for reusable arthroscopic instruments.
Frequently asked questions
What types of orthopedic surgeries is the Arthro-Surgimat-2000 ECU designed to assist with?
The Arthro-Surgimat-2000 ECU is specifically designed for arthroscopic surgery, allowing surgeons to visualize and irrigate joint spaces. This enables precise diagnostic evaluations and therapeutic interventions in procedures like knee, shoulder, or hip arthroscopy, where clear visualization of internal structures is critical.
Is the Arthro-Surgimat-2000 ECU a single-use or reusable device, and what does that mean for its maintenance?
The Arthro-Surgimat-2000 ECU is a reusable arthroscope, meaning it is intended for multiple uses after proper cleaning, sterilization, and maintenance. As a reusable device, it must be handled according to standard protocols for arthroscopic instruments to ensure sterility and functionality between procedures, including cleaning, disinfection, and sterilization cycles.
How is the device’s regulatory status relevant to its use in a clinical setting?
The Arthro-Surgimat-2000 ECU holds FDA 510(k) clearance (K990443) under the Orthopedic review panel, classified as substantially equivalent to prior devices. This means it has been evaluated and determined to meet regulatory standards for safety and effectiveness in controlled surgical environments, ensuring its use adheres to established medical device guidelines.
What does the “Special” classification under the Orthopedic review panel imply about the device’s intended use?
The ‘Special’ classification under the Orthopedic review panel indicates that the Arthro-Surgimat-2000 ECU is intended for specialized orthopedic procedures requiring precise visualization and irrigation within joint spaces. This classification reflects its role in advanced arthroscopic techniques, where careful handling and regulatory oversight are necessary to ensure patient safety and procedural accuracy.
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: ARTHRO-SURGIMAT-2000 ECU 510 (k) K990443 - FDA.report, ARTHRO-SURGIMAT-2000 ECU (K990443) — FDA 510 (k) | Innolitics, W.O.M. World of Medicine GmbH FDA 510(k) Products - Latest 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990443 | Class II | Active |
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Manufacturer
- Manufacturer
- W.O.M. World of Medicine GmbH
Sources (1)
- FDA 510(k) K990443 24 fields · synced Oct 6, 2026