Manan Galactography Kit

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

510(k) Number

K980227 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Manan D Bag

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  FDA 510(k) K980005 Active Cleared 30 Jan 1998

• Ultra-Core Biopsy Needles

  Class I

  FDA 510(k) K921418 Active Cleared 19 Jun 1992

• Techna-Cut Aspiration Needle

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  FDA 510(k) K974766 Active Cleared 8 Jan 1998

• Pbn Drainage Catheter Guidewires

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  FDA 510(k) K991097 Active Cleared 23 Apr 1999

• Md Tech Biopsy Set for Bone and Bone Marrow Open recall

  Class II

  FDA 510(k) K980196 Active Cleared 3 Feb 1998

See all devices from Medical Device Technologies, Inc. →

• What is the Manan Galactography Kit used for?

  The Manan Galactography Kit is designed for contrast-enhanced radiography of mammary ducts. It allows clinicians to inject contrast media into the breast ducts, improving radiographic imaging to identify abnormalities such as strictures, obstructions, or lesions. This helps diagnose conditions like mastitis, fibrocystic changes, or suspected malignancy by visualizing the ductal system.

• Is the Manan Galactography Kit reusable or single-use?

  The available data does not specify whether the Manan Galactography Kit is reusable or single-use. If reusable, it should follow standard reprocessing protocols to ensure safety and sterility. For single-use, adherence to manufacturer guidelines for handling and disposal is recommended.

• Can this device be used with MRI equipment?

  No, the Manan Galactography Kit is not indicated for use with MRI equipment. It is designed specifically for compatibility with standard radiographic equipment, ensuring accurate imaging of breast ducts through contrast-enhanced radiography.

• What regulatory approval does the Manan Galactography Kit hold?

  The Manan Galactography Kit was cleared under the FDA 510(k) process with the reference number K980227. It was determined to be substantially equivalent to a predicate device, meeting regulatory standards for diagnostic imaging devices in clinical settings.

• How should the Manan Galactography Kit be stored?

  While specific storage instructions are not detailed in the available data, standard aseptic practices should be followed if sterility is required. If reusable, store in a clean, dry environment away from direct sunlight or extreme temperatures. Always refer to manufacturer guidelines for optimal handling and preservation.