Cleared Traditional

K843975 - 9 FRENCH 42LONG POLYURETHANE GRADUATED ...

K843975 is the FDA 510(k) clearance for 9 FRENCH 42LONG POLYURETHANE GRADUATED ... by Superior Plastic Products Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K843975 · Superior Plastic Products Corp. · Gastroenterology & Urology device
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Nov 1984
Decision
40d
Days
Class 2
Risk

K843975 is an FDA 510(k) clearance for the 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Superior Plastic Products Corp. (Cumberland, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Superior Plastic Products Corp. devices

Submission Details

510(k) Number K843975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 20, 1984
Days to Decision 40 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
90d faster than avg
Panel avg: 130d · This submission: 40d
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 209
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K843975.
IVAC KEOFEED II POLYURETHANE FEEDING TUBE
K850182 · Y · Mar 1985
ENTRON ENTERAL FEEDING BAG
K850134 · Biosearch Medical Products, Inc. · Feb 1985
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · Biosearch Medical Products, Inc. · Dec 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · Y · Aug 1984
GORE-TEX CATHETER
K840864 · W.L. Gore & Associates, Inc. · Jun 1984