Cleared Traditional

K981323 - COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE

K981323 is an FDA 510(k) clearance for COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE, manufactured by Novartis Nutrition Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K981323 · Novartis Nutrition Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
179d
Days
Class 2
Risk

K981323 is an FDA 510(k) clearance for the COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Novartis Nutrition Corp. (Minneapolis, US). The FDA issued a Cleared decision on October 9, 1998 after a review of 179 days - an extended review cycle.

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 Novartis Nutrition Corp. devices

FDA 510(k) Submission Details - K981323

510(k) Number K981323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date October 09, 1998
Days to Decision 179 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 131d · This submission: 179d
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 511
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K981323.
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)
K990127 · Corpak Medsystems · Feb 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
TRIP TONOMETRY CATHETER, 16F
K983366 · Datex-Engstrom, Inc. · Dec 1998
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894 · Ballard Medical Products · Sep 1998
A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
K971434 · Applied Medical Technologies · Aug 1998
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · Rusch Intl. · Jun 1998