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Ross Enteral Feeding Tube

by Ross Products

510(k) K972437

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 NumberK972437 Date26 Jan 1998ClearedStatusActive

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  • Withdrawn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
FPD
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 Ross Enteral Feeding Tube is a medical device classified as a feeding tube. It functions as a conduit to facilitate enteral feeding for pediatric, adult, or elderly patients who are unable to consume an adequate diet orally.

This device has received FDA 510(k) clearance under the regulation number 876.5980. It is intended for direct placement in the small bowel for patients with a functioning gut who require nutritional support.

Other devices from Ross Products

Questions

AI-generated answers, 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.

  • What is the primary purpose of the Ross Enteral Feeding Tube?

    This device serves as a conduit for enteral feeding. It is specifically intended for pediatric, adult, and elderly patients who have a functioning gut but are unable to consume an adequate diet orally, requiring direct nutritional support in the small bowel.

  • Has this device received regulatory authorization?

    Yes, the Ross Enteral Feeding Tube has received FDA 510(k) clearance under regulation number 876.5980. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.

  • Which medical specialties are associated with this device?

    The device is categorized under the Gastroenterology and Urology advisory committees. This classification reflects its intended use for enteral nutrition delivery within the gastrointestinal tract.