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Percutaneous Endoscopic Gastrostomy Kit

by Ethox Corp. 510(k)

Active United States

510(k) K885220

Overview

The Percutaneous Endoscopic Gastrostomy Kit is a medical device classified under Tubes, Gastrointestinal (and Accessories). It is designed for the placement of a feeding tube directly into the stomach via the abdominal wall under endoscopic guidance, providing nutritional support for patients who cannot ingest food orally.

This kit is intended for single-use and requires endoscopic visualization for proper insertion. Supplied sterile, it is regulated under FDA 510(k) clearance (K885220) and falls under product code KNT, classified as Class II with Special Controls. Authorized for use in gastroenterology and urology procedures, it adheres to regulatory standards established by the FDA.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SEKD Traditional NumberK885220 Date25 Sep 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SEKD

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Questions

  • What types of patients is this Percutaneous Endoscopic Gastrostomy Kit designed to support with nutrition?

    This kit is specifically designed for patients who are unable to ingest food orally and require nutritional support. It allows for the direct placement of a feeding tube into the stomach through the abdominal wall, ensuring reliable access for enteral nutrition under endoscopic guidance.

  • Is this kit intended for reuse or is it meant to be used only once?

    The kit is explicitly labeled for single-use only, meaning it should not be reused after one procedure. This ensures patient safety and sterility, as it is supplied sterile and designed for one-time use.

  • How is the kit supplied, and what should I check before using it?

    The kit is supplied sterile and ready for use. Before opening, verify the sterility seal is intact and inspect for any visible damage or contamination. Since it requires endoscopic visualization for proper insertion, ensure your endoscopy equipment is calibrated and functional before proceeding.

  • What regulatory pathway does this device follow, and which committees were involved in its approval?

    This kit follows the FDA 510(k) clearance pathway, with the submission reviewed by the Gastroenterology and Urology (GU) Advisory Committee. The clearance was granted under Traditional 510(k) review and assigned the product code KNT, classified as a Class II device with Special Controls.