Cleared Traditional

K934772 - GASTRONOMY TUBE HOLDER

K934772 is an FDA 510(k) clearance for GASTRONOMY TUBE HOLDER, manufactured by Nelmed Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K934772 · Nelmed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
146d
Days
Class 2
Risk

K934772 is an FDA 510(k) clearance for the GASTRONOMY TUBE HOLDER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Nelmed Corp. (North Attleboro, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 146 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 Nelmed Corp. devices

FDA 510(k) Submission Details - K934772

510(k) Number K934772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date February 28, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 130d · This submission: 146d
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 K934772.
E-Z PEG
K921680 · Mill-Rose Laboratory · May 1994
VYGON - ENTERAL FEEDING TUBE - POLYURETHANE
K925854 · Vygon Corp. · May 1994
WILSON-COOK BALLOON INFLATION DEVICE
K936168 · Wilson-Cook Medical, Inc. · Mar 1994
GASTROINTESTINAL FEEDING TUBE
K920703 · Wilson-Cook Medical, Inc. · Dec 1993
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K930456 · Interventional Therapeutics Corp. · Nov 1993
HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE
K932855 · Hollister, Inc. · Oct 1993