Cleared Traditional

ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE (K901134) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901134 · Fresenius Pharma · Gastroenterology & Urology device
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Jun 1990
Decision
100d
Days
Class 2
Risk

K901134 is an FDA 510(k) clearance for the ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Fresenius Pharma (New Brunswick, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Pharma devices

Submission Details

510(k) Number K901134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 12, 1990
Decision Date June 20, 1990
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K901134.
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · Abbott Laboratories · Nov 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · Abbott Laboratories · Nov 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023 · Medline Industries, Inc. · Jul 1990
MAGNET RETRIEVAL CATHETER
K900852 · Cook, Inc. · May 1990
BARD GASTROSTOMY FEEDING DEVICE
K890870 · C.R. Bard, Inc. · Apr 1989
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · C.R. Bard, Inc. · Apr 1989