Cleared Traditional

K831970 - VIVONEX TUNGSTEN TIP TUBE-MONOFILA-

K831970 is the FDA 510(k) clearance for VIVONEX TUNGSTEN TIP TUBE-MONOFILA- 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 28-day FDA review.

K831970 · Norwich Eaton Pharmaceuticals, Inc. · Gastroenterology & Urology device
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Jul 1983
Decision
28d
Days
Class 2
Risk

K831970 is an FDA 510(k) clearance for the VIVONEX TUNGSTEN TIP TUBE-MONOFILA-. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Norwich Eaton Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 28 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 K831970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date July 18, 1983
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
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 K831970.
ENTERNAL FEEDING TUBE
K832293 · Concept, Inc. · Sep 1983
FOUR LUMEN BLAKEMORE TUBE
K832672 · Inmed Corp. · Sep 1983
FEEDING TUBE PLACEMENT STYLET
K831840 · Biosearch Medical Products, Inc. · Aug 1983
STOMACH TUBE LEVIN TUBE
K831974 · Medline Industries, Inc. · Jul 1983
BROOKS SCLEROTHERAPY CUFF
K823475 · Inmed Corp. · Jul 1983
DOBBHOFF FEEDING TUBE W/HYDROMER LUB
K831868 · Biosearch Medical Products, Inc. · Jul 1983