L.T.C. Feeding Tube

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

510(k) Number

K895616 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• L.T.C. Percutaneous Endoscopic Gastrostomy Tube

  Class II

  FDA 510(k) K897181 Active Cleared 27 Mar 1990

• L.T.C. Enteral Bag Administration Set W/Pump Set

  Class II

  FDA 510(k) K895824 Active Cleared 13 Mar 1990

• L.T.C. 1000 Urinary Drainage Bag

  Class II

  FDA 510(k) K895957 Active Cleared 24 Oct 1989

• L.T.C. Replacement Gastrostomy Tube

  Class I

  FDA 510(k) K896621 Active Cleared 13 Mar 1990

• What types of patients is the L.T.C. Feeding Tube designed for, and where can it be used?

  The L.T.C. Feeding Tube is designed for patients who require enteral nutrition support when oral intake is inadequate or impossible. It is intended for administration of liquid nutrients directly into the stomach or small intestine via nasogastric or orogastric routes. Due to its classification under product code KNT, it is suitable for use in both hospital and home settings, provided proper sizing and insertion techniques are followed to ensure patient safety.

• Is the L.T.C. Feeding Tube sterile, and how many times can it be used?

  The L.T.C. Feeding Tube is supplied as a single-use, non-sterile product. This means it is intended for one-time clinical use only and should not be reused. Sterility is not a claim or requirement for this device, so reprocessing or reuse is not recommended or supported.

• How was the FDA clearance for this device determined, and which committees were involved?

  The L.T.C. Feeding Tube received FDA clearance through a traditional 510(k) review process, determined to be substantially equivalent to a legally marketed device. The review was conducted under the Gastroenterology and Urology (GU) advisory committees, reflecting its classification under product code KNT for enteral feeding tubes. The decision was finalized on October 24, 1989.

• What sizes or models of the L.T.C. Feeding Tube are available, and how should it be stored?

  The specifications provided do not explicitly list available sizes or models of the L.T.C. Feeding Tube, so those details would need to be confirmed directly with the manufacturer, International Medical Marketing, Inc.. Regarding storage, since it is a non-sterile, single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following the manufacturer’s instructions to maintain its integrity until use.