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Compat Nasojejunal Feeding Tube

by Sandoz Nutrition

510(k) K961664

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 NumberK961664 Date4 Oct 1996ClearedStatusActive

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  • Withdrawn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, 19 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 Compat Nasojejunal Feeding Tube is a dual-lumen nasojejunal feeding device designed for enteral nutrition delivery while simultaneously providing gastric drainage. It is classified as a nasoenteric tube under FDA nomenclature, facilitating simultaneous feeding and suction in patients requiring both functions.

This device is intended for single-use and is supplied sterile. It is regulated under FDA 510(k) clearance (K961664) and is intended for use in clinical settings where dual-lumen access is necessary. No additional regulatory approvals beyond the 510(k) clearance are stated in the specifications.

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