Superdimension Marker Delivery Kit

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

510(k) Number

K110093 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Superdimension Nitinol/Gold Fiducial Marker

  Class II

  FDA 510(k) K120796 Active Cleared 26 Oct 2012

• Inreach System

  Class II

  FDA 510(k) K080271 Active Cleared 31 Mar 2008

• Superdimension/Bronchus Premium

  Class II

  FDA 510(k) K052852 Active Cleared 14 Nov 2005

• Modification to Inreach System

  Class II

  FDA 510(k) K081379 Active Cleared 11 Jun 2008

• Modification to Superdimension/Bronchus Premium 2

  Class II

  FDA 510(k) K071473 Active Cleared 12 Jul 2007

• I-Logic Inreach System

  Class II

  FDA 510(k) K102604 Active Cleared 7 Oct 2010

See all devices from Superdimension, Ltd. →

• What clinical scenario is the SuperDimension Marker Delivery Kit designed to assist with, and why is precise marker placement important in this context?

  The SuperDimension Marker Delivery Kit is designed to assist in lung lesion localization during radiologic procedures, particularly for patients who will undergo subsequent thoracic or radiosurgical interventions. Precise marker placement within the bronchial tree ensures accurate lesion targeting, which is critical during dynamic respiratory motion—where the position of the lesion can shift—so that treatments like radiation therapy remain effective and avoid missing the target.

• Is this device meant for repeated use in the same patient, or is it intended as a single-use item, and how does that affect its sterility?

  The SuperDimension Marker Delivery Kit is explicitly labeled as a sterile, single-use device, meaning it is intended for one-time use in a single patient procedure. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is essential in radiology settings where infection control is paramount.

• What systems or equipment is this kit compatible with, and how does that integration improve the workflow for clinicians?

  The kit is designed to integrate with the superDimension i·Logic inReach System, a platform that likely provides real-time imaging guidance and navigation. This compatibility allows clinicians to deploy markers with greater precision during bronchoscopy or fluoroscopy, streamlining the localization process and reducing procedural uncertainty for subsequent interventions like radiation therapy.

• How should this device be stored, and what precautions should be taken to maintain its integrity before use?

  Since the SuperDimension Marker Delivery Kit is a sterile, single-use device, it must be stored according to sterile medical device protocols—typically in a sealed, protective packaging until the moment of use. Storage should follow manufacturer guidelines to prevent contamination, moisture exposure, or physical damage, ensuring the catheter and guidewire remain ready for immediate deployment in the radiology suite.