Skip to content

NAJA Gastrointestinal Catheter

by Chess Medical, Inc.

510(k) K223890

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 NumberK223890 Date16 Jun 2023ClearedStatusActive

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  • Withdrawn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
FGD
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 NAJA Gastrointestinal Catheter is a retention catheter designed for barium enema procedures. It is classified as a Class II medical device under the product code FGD and regulation number 876.5980.

This device is supplied non-sterile and is intended for single-use. It is used in gastroenterology and urology settings and has received FDA 510(k) clearance under K223890, with a traditional clearance pathway and substantial equivalence determination.

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the NAJA Gastrointestinal Catheter used for?

    The NAJA Gastrointestinal Catheter is designed for barium enema procedures as a retention catheter, used in gastroenterology and urology settings to retain contrast material during imaging.

  • Is the NAJA Gastrointestinal Catheter sterile or non-sterile, and is it reusable?

    The device is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after a procedure to ensure patient safety and device integrity.

  • What regulatory pathway was used for the NAJA Gastrointestinal Catheter?

    The NAJA Gastrointestinal Catheter received FDA 510(k) clearance under K223890 through a traditional clearance pathway, with a determination of substantial equivalence to a legally marketed predicate device.