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Nutricare Clear-ISOSAF Nasogastric Feeding Tube

by Three Circles Consulting Limited

510(k) K202357

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 NumberK202357 Date1 Oct 2020ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 22 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 Nutricare Clear-ISOSAF Nasogastric Feeding Tube is a gastrointestinal tube with enteral specific connectors designed for enteral feeding. It is inserted into the alimentary canal of pediatric patients via the nasal or oral cavity to facilitate the delivery of fluids, medications, or nutrition directly into the gastrointestinal tract.

This device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code PIF. It is classified as Class II - Special Controls for gastrointestinal tubes with enteral specific connectors. The device is manufactured by Three Circles Consulting Limited and is intended for use in pediatric patients from newborns to adolescents.

Questions

AI-generated answers, 22 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 Nutricare Clear-ISOSAF Nasogastric Feeding Tube used for?

    The Nutricare Clear-ISOSAF Nasogastric Feeding Tube is designed for enteral feeding in pediatric patients. It is inserted through the nasal or oral cavity to deliver fluids, medications, or nutrition directly into the gastrointestinal tract of patients ranging from newborns to adolescents.

  • Is the Nutricare Clear-ISOSAF Nasogastric Feeding Tube single-use or reusable?

    This device is supplied as a single-use product, meaning it should be discarded after one use to ensure patient safety and prevent cross-contamination. Reusing the tube could compromise its integrity and sterility.

  • What is the regulatory classification of the Nutricare Clear-ISOSAF Nasogastric Feeding Tube?

    The device is regulated under FDA 510(k) clearance with product code PIF and is classified as Class II - Special Controls for gastrointestinal tubes with enteral specific connectors. It received FDA clearance on October 1, 2020, with K number K202357.

  • Who is the manufacturer of the Nutricare Clear-ISOSAF Nasogastric Feeding Tube?

    The Nutricare Clear-ISOSAF Nasogastric Feeding Tube is manufactured by Three Circles Consulting Limited, located at Med Ic4, Keele University Science & Innovation Park, Keele, ST5 5NL, GB. The company is responsible for the production and quality control of this medical device.