Cleared Traditional

GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG (K891371) - FDA 510(k) Clearance

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

K891371 · Entech, Inc. · Gastroenterology & Urology device
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Aug 1989
Decision
147d
Days
Class 2
Risk

K891371 is an FDA 510(k) clearance for the GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Entech, Inc. (Lebanon, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 147 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 Entech, Inc. devices

Submission Details

510(k) Number K891371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received March 09, 1989
Decision Date August 03, 1989
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
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 K891371.
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
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · Abbott Laboratories · Dec 1988