Cleared Traditional

GASTROPORT II (K924308) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924308 · Sandoz Nutrition · Gastroenterology & Urology device
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Jul 1993
Decision
337d
Days
Class 2
Risk

K924308 is an FDA 510(k) clearance for the GASTROPORT II. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Sandoz Nutrition (Minneapolis, US). The FDA issued a Cleared decision on July 29, 1993 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sandoz Nutrition devices

Submission Details

510(k) Number K924308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 26, 1992
Decision Date July 29, 1993
Days to Decision 337 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 130d · This submission: 337d
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 123
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K924308.
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · Abbott Laboratories · Oct 1993
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · Abbott Laboratories · Aug 1993
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
K915841 · C.R. Bard, Inc. · Jun 1993
NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM
K915837 · C.R. Bard, Inc. · Mar 1993
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER
K921697 · Abbott Laboratories · Aug 1992