📋 FDA Reference

Percutaneous Endoscopic Gastrostomy (PEG) Kit

Degania Silicone Ltd

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Summary: A percutaneous endoscopic gastrostomy (PEG) kit contains the devices used to place a feeding tube through the abdominal wall into the stomach. It is used to provide enteral nutrition, fluids, and medications when oral intake is inadequate or unsafe.

FDA Clearance Information

Pathway ? 510(k)
Number ? K254170 ↗
Decision Date ? March 20, 2026
Product Code ? PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class ? Class 2
Evidence ? 0 studies

FDA-Cleared Indications

  • Enteral access to the stomach for delivery of nutrition, fluids, or medications.
  • Gastrointestinal decompression when indicated by the treating clinician.

Clinical Applications

  • Placement of a gastrostomy feeding tube through the abdominal wall into the stomach.
  • Delivery of enteral nutrition for patients who cannot obtain adequate nutrition by mouth.
  • Administration of fluids or medications through gastric enteral access.
  • Use as gastric access during gastrostomy-tube placement procedures.

Reported off-label uses

  • Conversion or use of the gastric access as part of selected gastrojejunostomy-tube placements when compatible components and labeling permit.
  • Gastric decompression in selected patients with obstruction or severe gastrointestinal dysfunction, when determined appropriate by the treating clinician.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

  • PEG kits are available with different tube diameters, lengths, retention systems, and connector configurations; selection should match the patient's anatomy, clinical needs, and replacement accessories.
  • The enteral connector must be compatible with feeding sets, syringes, extension tubing, and any planned jejunal components. Enteral connectors should not be connected to intravenous equipment.
  • Placement generally requires endoscopic visualization, sterile technique, local anesthesia with or without procedural sedation, and confirmation that the stomach can be safely accessed through the abdominal wall.
  • Potential contraindications or precautions include inability to safely access the stomach, major abdominal infection or peritonitis, uncorrected coagulopathy, and unstable medical conditions; patient-specific assessment is required.
  • MRI safety depends on the exact tube and any retained or removable components. Confirm the manufacturer's MRI labeling for the specific kit and tube before scanning.

Procedures that use this device

Frequently Asked Questions

What is a percutaneous endoscopic gastrostomy kit used for?

It is used to place a feeding tube through the abdominal wall into the stomach. The tube can deliver nutrition, fluids, and medications when eating or drinking by mouth is not adequate or safe.

Is a PEG tube MRI safe?

MRI safety depends on the specific PEG tube and its components. Check the device's manufacturer labeling and the MRI conditions before scanning.

What sizes do PEG tubes come in?

PEG tubes are available in multiple diameters and lengths, with different retention and connector designs. The appropriate size is selected based on the patient's anatomy, feeding needs, and replacement requirements.

How long does a PEG tube last?

There is no single lifespan for every PEG tube. A tube may remain functional for months or longer, but it may need earlier replacement because of clogging, leakage, infection, breakage, migration, or other complications.

How much does a PEG tube placement cost?

Cost varies with the facility, procedure, anesthesia or sedation, imaging and endoscopy services, hospitalization, and insurance coverage. The treating facility and insurer can provide the most accurate estimate.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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