Enteron Percutan Endoscopic Gastrostomy Tray-PEG

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

510(k) Number

K873360 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Oval Cup Biopsy Forcep

  Class II

  FDA 510(k) K911155 Active Cleared 7 Aug 1991

• Cleaning Brush

  Class I

  FDA 510(k) K874239 Active Cleared 29 Dec 1987

• Guide Wire

  Class I

  FDA 510(k) K874164 Active Cleared 7 Dec 1987

• Sheath, Endoscope

  Class II

  FDA 510(k) K862059 Active Cleared 4 Nov 1986

• Polypectomy Snare

  Class II

  FDA 510(k) K862060 Active Cleared 27 Jun 1986

• Endoscopic Retrograde Cholangiopancreatography

  Class II

  FDA 510(k) K860990 Active Cleared 13 May 1986

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• What types of patients is the Enteron Percutan Endoscopic Gastrostomy Tray-PEG designed for?

  The Enteron Percutan Endoscopic Gastrostomy Tray-PEG is specifically designed for patients who require long-term enteral nutrition support but are unable to consume adequate nutrition orally. It is intended for use in clinical settings where endoscopic procedures are performed, such as gastroenterology, to provide a secure method for placing feeding tubes directly into the stomach via the abdominal wall.

• Is the Enteron Percutan Endoscopic Gastrostomy Tray-PEG intended for single-use or reusable applications?

  The Enteron Percutan Endoscopic Gastrostomy Tray-PEG is supplied as a sterile, single-use tray. This design ensures patient safety and hygiene, as it is intended for one-time use in a clinical procedure before disposal.

• How should the Enteron Percutan Endoscopic Gastrostomy Tray-PEG be stored before use?

  The tray must be stored according to the manufacturer’s guidelines to maintain sterility and integrity. Since it is a sterile, single-use device, it should be kept in its original packaging until immediately before use, in a clean, dry environment protected from contamination or damage.

• What regulatory pathway does the Enteron Percutan Endoscopic Gastrostomy Tray-PEG follow?

  The Enteron Percutan Endoscopic Gastrostomy Tray-PEG is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K873360. It is classified under product code KNT and was determined to be substantially equivalent to a predicate device, adhering to FDA standards for endoscopic gastrostomy trays as outlined in regulation 876.5980.

• In what clinical specialties is the Enteron Percutan Endoscopic Gastrostomy Tray-PEG primarily used?

  The tray is primarily intended for use in gastroenterology and urology procedures, as it supports percutaneous endoscopic gastrostomy (PEG) placements. It is designed for professional medical use in clinical settings where these specialties perform endoscopic interventions requiring tube feeding access.