Cleared Traditional

K873343 - ENTUBE-MEER AND MEER FEEDING TUBE BRIDL...

K873343 is an FDA 510(k) clearance for ENTUBE-MEER AND MEER FEEDING TUBE BRIDL..., manufactured by Entech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K873343 · Entech, Inc. · Gastroenterology & Urology device
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Dec 1987
Decision
110d
Days
Class 2
Risk

K873343 is an FDA 510(k) clearance for the ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM. 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 December 7, 1987 after a review of 110 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

FDA 510(k) Submission Details - K873343

510(k) Number K873343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1987
Decision Date December 07, 1987
Days to Decision 110 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
20d faster than avg
Panel avg: 130d · This submission: 110d
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 K873343.
J-CATH(TM)
K875171 · Hdc Corp. · Apr 1988
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
K873360 · Endovations · Mar 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · Biosearch Medical Products, Inc. · Mar 1988
ENTERAL FEEDING TUBE
K874393 · Wilson-Cook Medical, Inc. · Dec 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · Abbott Laboratories · Aug 1987
ENTRIMIT GRAVITY FEEDING SET
K871528 · Biosearch Medical Products, Inc. · Aug 1987