Panda Needle Catheter Jejunostomy Tube

No FDA recalls on record, checked 22 Oct 2026.

Full name

Panda(R) Needle Catheter Jejunostomy Tube

510(k) Number

K891109 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Panda Needle Catheter Jejunostomy Tube used for?

  The Panda Needle Catheter Jejunostomy Tube is designed for percutaneous placement into the jejunum to provide a secure, minimally invasive route for enteral nutrition or gastrointestinal decompression. It eliminates the need for surgical intervention by combining a needle catheter system with a jejunostomy tube, making it ideal for patients requiring jejun access in clinical settings.

• How is the Panda Needle Catheter Jejunostomy Tube supplied?

  This device is supplied as a sterile, single-use product, ensuring safety and hygiene for hospital or clinical use. It is intended for one-time use per patient to maintain sterility and reduce infection risks, adhering to standard medical device protocols.

• Is the Panda Needle Catheter Jejunostomy Tube reusable?

  No, the Panda Needle Catheter Jejunostomy Tube is explicitly designed for single-use only. Reuse is not recommended or supported due to potential contamination risks and compromised sterility, which could affect patient safety and device performance.

• What storage conditions are required to maintain sterility?

  Proper storage conditions must be maintained to preserve the sterility of the Panda Needle Catheter Jejunostomy Tube. This includes keeping the device in its original, unopened packaging until immediate use, away from direct sunlight, extreme temperatures, and moisture. Follow manufacturer guidelines to ensure the device remains sterile and functional.

• Can the Panda Needle Catheter Jejunostomy Tube be used in MRI procedures?

  No, the Panda Needle Catheter Jejunostomy Tube is explicitly stated as not MRI-safe. This means it should not be used in or near MRI equipment, as the magnetic fields could cause damage to the device or pose risks to the patient.