Cleared Traditional

K950017 - FLEXIFLO FLOCATOR SMALL BOWEL FEEDING S...

K950017 is an FDA 510(k) clearance for FLEXIFLO FLOCATOR SMALL BOWEL FEEDING S..., manufactured by Ross Products. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 801-day FDA review.

K950017 · Ross Products · Gastroenterology & Urology device
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Mar 1997
Decision
801d
Days
Class 2
Risk

K950017 is an FDA 510(k) clearance for the FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ross Products (Columbus, US). The FDA issued a Cleared decision on March 14, 1997 after a review of 801 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Ross Products devices

FDA 510(k) Submission Details - K950017

510(k) Number K950017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date March 14, 1997
Days to Decision 801 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
671d slower than avg
Panel avg: 130d · This submission: 801d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K950017.
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
K973409 · Davis & Geck, Inc. · Feb 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · Applied Medical Resources · Jan 1998
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · Boston Scientific Corp · Sep 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181 · United States Endoscopy Group, Inc. · Jun 1996