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Rombeau Gastrostomy-Jejunal Tube

by Hedeco

510(k) K822380

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822380 Date17 Sep 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rombeau Gastrostomy-Jejunal Tube is a medical device designed for patients requiring long-term tube enterostomy feeding. It functions as a combined gastrostomy-jejunal tube that allows for simultaneous gastric decompression and the delivery of nutritional formula directly into the jejunum.

This device is intended to assist patients with neurologic or mechanical deficits who are at an increased risk for aspiration. The product has received FDA 510(k) clearance.

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