Cleared Traditional

K970178 - CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM

K970178 is an FDA 510(k) clearance for CLOG ZAPPER ENTERAL FEEDING TUBE DECLOG..., manufactured by Corpak, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K970178 · Corpak, Inc. · Gastroenterology & Urology device
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Jul 1997
Decision
185d
Days
Class 2
Risk

K970178 is an FDA 510(k) clearance for the CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Corpak, Inc. (Wheeling, US). The FDA issued a Cleared decision on July 21, 1997 after a review of 185 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 Corpak, Inc. devices

FDA 510(k) Submission Details - K970178

510(k) Number K970178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1997
Decision Date July 21, 1997
Days to Decision 185 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 131d · This submission: 185d
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 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K970178.
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997
LOW PROFILE FEEDING SET ACCESSORY
K971757 · Applied Medical Technologies · Nov 1997
ENTERAL NUTRITION 1000 ML/500ML
K970849 · Medical Infusion Technologies, Inc. · Aug 1997
RPI DUAL PORT IRRIGATION ADAPTER
K964920 · Ridge Products, Inc. · Jul 1997
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
K971230 · Innerdyne, Inc. · Jun 1997
#ES-32 SUCTION CATHETER 32 FR.
K970890 · Tri-Med Specialties, Inc. · May 1997