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Flexiflo Flocator Small Bowel Feeding System

by Ross Products

510(k) K950017

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 NumberK950017 Date14 Mar 1997ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Flexiflo Flocator Small Bowel Feeding System is a gastrointestinal feeding tube designed for enteral nutrition delivery into the small bowel. It features a flocator mechanism to prevent clogging and ensure reliable flow of liquid nutrients, reducing the risk of occlusion during use. This system is intended for patients requiring small bowel feeding, such as those with gastrointestinal disorders or postoperative recovery needs.

This device is supplied as a reusable component set, including a feeding tube and associated accessories for small bowel access. It is intended for use in clinical settings such as hospitals or outpatient care facilities, where sterile techniques are maintained. The system is classified under product code KNT (Tubes, Gastrointestinal (and Accessories)) and holds an FDA 510(k) clearance (K950017) under the Gastroenterology/Urology advisory committee. Storage and handling must comply with manufacturer guidelines to preserve sterility and functionality.

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