Cleared Traditional

K841330 - GASTROSTOMY FEEDING TUBE

K841330 is an FDA 510(k) clearance for GASTROSTOMY FEEDING TUBE, manufactured by Microvasive. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841330 · Microvasive · Gastroenterology & Urology device
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May 1984
Decision
50d
Days
Class 2
Risk

K841330 is an FDA 510(k) clearance for the GASTROSTOMY FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Microvasive (Walker, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 50 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 Microvasive devices

FDA 510(k) Submission Details - K841330

510(k) Number K841330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date May 22, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
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 480
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K841330.
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · Burron Medical Products, Inc. · Jul 1984
RECTAL IRRIGATION TUBE
K841289 · Hdc Corp. · Jul 1984
GORE-TEX CATHETER
K840864 · W.L. Gore & Associates, Inc. · Jun 1984
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K840752 · E-Z-Em, Inc. · May 1984
WEIGHTED FEEDING TUBE W/PRE-INSERTED
K841014 · Ethox Corp. · May 1984
MILLER-ABBOTT TUBE
K841033 · Inmed Corp. · Apr 1984