Cleared Traditional

K861309 - JEJUNAL FEEDING TUBE

K861309 is an FDA 510(k) clearance for JEJUNAL 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 252-day FDA review.

K861309 · Microvasive · Gastroenterology & Urology device
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Dec 1986
Decision
252d
Days
Class 2
Risk

K861309 is an FDA 510(k) clearance for the JEJUNAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 252 days - an extended review 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: 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 Microvasive devices

FDA 510(k) Submission Details - K861309

510(k) Number K861309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date December 16, 1986
Days to Decision 252 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
121d slower than avg
Panel avg: 131d · This submission: 252d
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 K861309.
MIC MUSHROOM TIP GASTROSTOMY TUBE
K872531 · Medical Innovations Corp. · Sep 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · Abbott Laboratories · Aug 1987
ENTRIMIT GRAVITY FEEDING SET
K871528 · Biosearch Medical Products, Inc. · Aug 1987
REPLACEMENT GASTROSTOMY TUBE
K861323 · Microvasive · Dec 1986
ENTERAL ADMINISTRATION ADAPTERS
K864182 · Biosearch Medical Products, Inc. · Dec 1986
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · Henley Intl. · Nov 1986