9 French 42LONG Polyurethane Graduated Enteric Fe

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

510(k) Number

K843975 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Tracheostomy Care Kit Open recall

  Class II

  FDA 510(k) K761190 Active Cleared 16 Dec 1976

• 3.5 & 5.5 Oz. Sodium Chloride Solution

  Class II

  FDA 510(k) K820460 Active Cleared 8 Mar 1982

• Enteral Feeding Bottle

  Class II

  FDA 510(k) K841945 Active Cleared 26 Jul 1984

• Dispos. Enteric Feeding Tubes W/Safe-T

  Class II

  FDA 510(k) K833687 Active Cleared 2 Mar 1984

• Enteral Nutrition Pump

  Class II

  FDA 510(k) K841630 Active Cleared 7 Jun 1984

• Silicone Sump Drain 20 & 40 French

  Class I

  FDA 510(k) K840324 Active Cleared 25 Apr 1984

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• What clinical specialties commonly use this feeding tube, and why is it designed for single-use?

  This 9 French polyurethane enteric feeding tube is primarily used in gastroenterology and urology procedures. It is designed for single-use to ensure patient safety and hygiene, as reuse could introduce contamination risks. The sterile packaging and single-use nature align with clinical protocols for enteral nutrition delivery to minimize infection risks during sensitive procedures.

• How does the graduated marking help in clinical use, and what length and size should clinicians expect?

  The graduated markings on this tube allow clinicians to precisely measure and confirm placement within the gastrointestinal tract, ensuring accurate positioning for enteral nutrition delivery. The tube is 9 French in diameter and 42 inches long, making it suitable for patients requiring moderate-length feeding access while maintaining visibility for placement verification.

• What storage and handling precautions must be taken to maintain sterility before use?

  Since this tube is supplied sterile, it must be stored in its original packaging until ready for use to preserve sterility. Handling should follow standard sterile medical device protocols, including avoiding contamination from surfaces, air, or personnel. Any breach in packaging integrity should prompt discarding to prevent infection risks during clinical procedures.

• Is this tube compatible with standard enteral nutrition systems, and how does its polyurethane construction benefit patients?

  While the device data does not specify compatibility with specific systems, the 9 French polyurethane construction is designed for flexibility and durability in enteral nutrition delivery. Polyurethane is biocompatible and resistant to degradation from feeding formulas, reducing the risk of tube failure or patient discomfort during prolonged use.