Cleared Traditional

K880201 - REPLACEMENT SILICONE GASTROSTOMY TUBE K...

K880201 is the FDA 510(k) clearance for REPLACEMENT SILICONE GASTROSTOMY TUBE K... by Superior Healthcare Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K880201 · Superior Healthcare Group, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
90d
Days
Class 2
Risk

K880201 is an FDA 510(k) clearance for the REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Superior Healthcare Group, Inc. (Cumberland, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 90 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 Superior Healthcare Group, Inc. devices

Submission Details

510(k) Number K880201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date April 14, 1988
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 206
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K880201.
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · Abbott Laboratories · Dec 1988
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT
K884309 · Biosearch Medical Products, Inc. · Dec 1988
DENT SLEEVE MANOMETRIC CATHETER
K881310 · Wilson-Cook Medical, Inc. · May 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