UNIDRIVE SIII System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K223520 ↗

FDA Product Code

HIH

FDA applicant

Karl Storz-Endoscopy-America, Inc.

Device Class

Class II

Regulation

21 CFR Part 884.1690

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Karl Storz Endoscopy-America, Inc. →

• What is the Unidrive SIII System used for in clinical practice?

  The Unidrive SIII System is designed for both diagnostic and therapeutic procedures in obstetrics and gynecology. Clinicians use it to visualize and assess anatomical structures within the uterine cavity, diagnose conditions like polyps or fibroids, and perform minimally invasive interventions such as tissue sampling or ablation. The integrated imaging technology and motorized control enhance procedural accuracy and improve patient comfort during these procedures.

• How is the Unidrive SIII System supplied, and is it reusable?

  The Unidrive SIII System is supplied as a reusable device, intended for use in clinical settings such as outpatient clinics, hospitals, or surgical centers. Its reusable design allows for repeated use after adhering to the manufacturer’s sterilization guidelines, ensuring safety and functionality over multiple procedures. Each accessory part is assigned a unique FEI number for traceability, which helps maintain inventory and compliance.

• What sterilization procedures should be followed for the Unidrive SIII System?

  The Unidrive SIII System must undergo sterilization procedures as outlined by the manufacturer to maintain its safety and functionality for reuse. Since it is a reusable Class II device, proper sterilization is critical to prevent contamination and ensure reliable performance. Always refer to the manufacturer’s instructions for specific sterilization methods, such as autoclaving or chemical sterilization, to avoid damaging the device or compromising its sterility.

• Are there specific sizes or models included with the Unidrive SIII System?

  The Unidrive SIII System includes multiple accessory parts, each with a unique FEI number for traceability. While the exact sizes or specific models of these accessories are not detailed in the provided data, the system is designed to accommodate various procedural needs in obstetrics and gynecology. For precise sizing or model selection, consult the manufacturer’s documentation or catalog, which likely outlines the range of compatible accessories for the system.

• Does the Unidrive SIII System have any special handling or storage requirements?

  The Unidrive SIII System should be stored in a clean, dry environment to prevent damage or contamination between uses. Since it is reusable, proper cleaning and sterilization are essential before storage. Additionally, accessories should be stored according to manufacturer guidelines to maintain their integrity and functionality. No specific MRI safety information is provided, so ensure the system is not exposed to MRI environments unless confirmed safe by the manufacturer.