Cleared Traditional

K982500 - CHAIT CECOSTOMY CATHETER

K982500 is an FDA 510(k) clearance for CHAIT CECOSTOMY CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K982500 · Cook, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
191d
Days
Class 2
Risk

K982500 is an FDA 510(k) clearance for the CHAIT CECOSTOMY CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 27, 1999 after a review of 191 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 Cook, Inc. devices

FDA 510(k) Submission Details - K982500

510(k) Number K982500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date January 27, 1999
Days to Decision 191 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
60d slower than avg
Panel avg: 131d · This submission: 191d
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 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K982500.
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
K983476 · Navion Biomedical Corp. · Mar 1999
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
K984310 · Moss Tubes, Inc. · Feb 1999
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)
K990127 · Corpak Medsystems · Feb 1999
TRIP TONOMETRY CATHETER, 16F
K983366 · Datex-Engstrom, Inc. · Dec 1998
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
K981323 · Novartis Nutrition Corp. · Oct 1998
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894 · Ballard Medical Products · Sep 1998