Cleared Traditional

K821231 - VIVONEX TUNGSTEN TIP TUBE PLACEMENT

K821231 is the FDA 510(k) clearance for VIVONEX TUNGSTEN TIP TUBE PLACEMENT by Norwich Eaton Pharmaceuticals, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K821231 · Norwich Eaton Pharmaceuticals, Inc. · Gastroenterology & Urology device
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May 1982
Decision
13d
Days
Class 2
Risk

K821231 is an FDA 510(k) clearance for the VIVONEX TUNGSTEN TIP TUBE PLACEMENT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Norwich Eaton Pharmaceuticals, Inc. (Walker, US). The FDA issued a Cleared decision on May 10, 1982 after a review of 13 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 Norwich Eaton Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K821231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date May 10, 1982
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
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 284
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K821231.
ARGYLE DUO-TUBE
K822631 · Sherwood Medical Co. · Sep 1982
NASO-GARD NASOGASTRIC TUBE HOLDER
K822443 · American Pharmaseal Div. Ahsc · Sep 1982
CONPHAR SILICONE FEEDING TUBE
K821825 · Conphar, Inc. · Aug 1982
AM. PH. STERILE FEEDING TUBE
K820420 · American Pharmaseal Div. Ahsc · Mar 1982
ARGYLE PVC FEEDING TUBE
K820441 · Sherwood Medical Co. · Mar 1982
ARGYLE INDWELL FEEDING TUBE
K820442 · Sherwood Medical Co. · Mar 1982