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Medi-Globe Ultrasound Needle System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990220

by Medi-Globe Corp.

Identifiers

510(k) Number
K990220 FDA 510(k)
FDA Product Code
FCG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medi-Globe Ultrasound Needle System is a Biopsy Needle (product code FCG) designed for ultrasonically guided fine needle aspiration (FNA). It is intended for sampling submucosal and extraluminal lesions, including pancreatic, mediastinal, and peri-pancreatic masses, as well as lymph nodes, under ultrasound visualization.

This device is supplied as a reusable system and is classified under FDA’s Special Controls for Class II devices (regulation number 876.1075). It was modified and cleared via an FDA 510(k) submission (K990220) in 1999, with no third-party involvement. Multiple model references are associated with the system, though specific sterility or MRI safety details are not provided in the regulatory data.

Frequently asked questions

What types of lesions and tissues can the Medi-Globe Ultrasound Needle System be used to sample under ultrasound guidance?

The Medi-Globe Ultrasound Needle System is designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extraluminal lesions, including pancreatic, mediastinal, and peri-pancreatic masses. It is also suitable for sampling lymph nodes, making it versatile for procedures in gastroenterology and urology.

Is the Medi-Globe Ultrasound Needle System intended for single-use or reusable applications?

The device is explicitly described as a reusable system in the regulatory data, meaning it is not designed for single-use and must be processed and sterilized between procedures.

How many model references are associated with this ultrasound needle system, and what does this indicate?

The system includes multiple model references (listed in the regulatory data), which suggests there are various configurations or gauges available. This variability allows clinicians to select the appropriate needle size for different procedural needs, though specific details on individual models (e.g., gauge, length) are not provided in the data.

What medical specialties are primarily associated with the use of this ultrasound needle system?

The device is classified under gastroenterology and urology specialties, as indicated by the advisory committee (GU) and medical specialty descriptions in the regulatory submission. This reflects its intended use for procedures in those fields, such as sampling pancreatic or lymph node lesions.

What regulatory pathway was followed for the clearance of this device, and when was it originally cleared?

The Medi-Globe Ultrasound Needle System was cleared via an FDA 510(k) submission (K990220) in 1999, with a determination of substantial equivalence to a predicate device. The clearance was granted under Class II special controls (regulation number 876.1075) and involved no third-party involvement in the process.

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: Modification of Gip/Medi-globe Ultrasound Needle System, K990220 FDA 510(k) - MODIFICATION OF GIP/MEDI-GLOBE ULTRASOU..., K990220 FDA 510(k) - MODIFICATION OF GIP/MEDI-GLOBE ULTRASOU..., K990220 FDA 510(k) - MODIFICATION OF GIP/MEDI-GLOBE ULTRASOU...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medi-Globe Corp.

Sources (1)

  • FDA 510(k) K990220 24 fields · synced Oct 6, 2026