Injection Needle Probe/Device-Tunis

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

510(k) Number

K983765 ↗

FDA Product Code

FBK

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Electrodes/Probes/Devices

  Class II

  FDA 510(k) K974637 Active Cleared 7 Jan 1998

• Isolated Saline Electrodes/Probes/Devices-Salinetrode

  Class II

  FDA 510(k) K981256 Active Cleared 12 May 1998

• Bipolar Electrosurgical Probes and Instruments

  Class II

  FDA 510(k) K945995 Active Cleared 31 Jan 1995

• Electrosurgical Probes and Devices-Geltx

  Class II

  FDA 510(k) K002269 Active Cleared 4 Jan 2001

• Isolated Electrosurgical Probes and Devices-Salinetrode

  Class II

  FDA 510(k) K974484 Active Cleared 10 Feb 1998

• Injection/Aspiration Needles Probes/Devices-Tpi/Tpi Flex

  Class I

  FDA 510(k) K983200 Active Cleared 11 Dec 1998

See all devices from Ximed/Prosure/Injectx →

• What medical specialties is this endoscopic injection needle primarily used in, and why is it designed for those fields?

  This device is primarily used in gastroenterology and urology procedures. It is designed for these specialties because it is an endoscopic injection needle, which allows for precise delivery of substances (such as sclerosants, contrast agents, or therapeutic agents) during minimally invasive interventions like ERCP (endoscopic retrograde cholangiopancreatography) or cystoscopy. Its specialized construction enables controlled injection within confined anatomical spaces, making it ideal for these fields.

• Is this device reusable, or is it intended for single-use only? What does that mean for clinical workflows?

  This device is intended for single-use only, meaning it is supplied sterile and should not be reused after a single procedure. This design choice reduces the risk of contamination and infection, ensuring patient safety. Clinically, this means each procedure requires a new device, which may impact inventory management and sterilization workflows—though no additional handling instructions are specified beyond standard sterile medical device protocols.

• How do I know if this device is compatible with my existing endoscopic equipment, and are there any special handling requirements?

  While the device is intended for endoscopic use (as indicated by its classification under product code FBK and regulatory submission), compatibility with specific endoscopic systems depends on your equipment’s manufacturer specifications. The device is not MRI-compatible, so it should not be used in MRI environments. No additional storage or handling requirements are provided beyond standard sterile medical device protocols, so ensure it is stored in a clean, dry environment away from direct sunlight or extreme temperatures.

• What does the FDA’s Traditional 510(k) review pathway mean for this device, and how does that affect its use in clinical settings?

  The Traditional 510(k) review pathway means this device was evaluated by the FDA to determine it is substantially equivalent to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for its intended use. Clinically, this means the device has undergone regulatory scrutiny for use in controlled clinical settings, such as hospitals or specialized outpatient centers, where endoscopic procedures are performed. It does not imply any restrictions on its use beyond standard sterile, single-use protocols.