Cleared Traditional

K883351 - PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEE...

K883351 is an FDA 510(k) clearance for PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEE..., manufactured by Gastrotech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K883351 · Gastrotech, Inc. · Gastroenterology & Urology device
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Aug 1988
Decision
14d
Days
Class 2
Risk

K883351 is an FDA 510(k) clearance for the PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Gastrotech, Inc. (Independence, US). The FDA issued a Cleared decision on August 23, 1988 after a review of 14 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 Gastrotech, Inc. devices

FDA 510(k) Submission Details - K883351

510(k) Number K883351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date August 23, 1988
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K883351.
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · Abbott Laboratories · Dec 1988
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT
K884309 · Biosearch Medical Products, Inc. · Dec 1988
KIM NASO-INTESTINAL TUBE
K882918 · Sheridan Catheter Corp. · Dec 1988
DENT SLEEVE MANOMETRIC CATHETER
K881310 · Wilson-Cook Medical, Inc. · May 1988
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
K874154 · Electro-Catheter Corp. · Apr 1988
MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K874936 · Medsurg Industries, Inc. · Apr 1988