Cleared Traditional

K781230 - GAVAGE ADMIN. SET

K781230 is an FDA 510(k) clearance for GAVAGE ADMIN. SET, manufactured by Mcgaw Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K781230 · Mcgaw Laboratories · Gastroenterology & Urology device
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Sep 1978
Decision
51d
Days
Class 2
Risk

K781230 is an FDA 510(k) clearance for the GAVAGE ADMIN. SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Mcgaw Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 51 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.

FDA 510(k) Submission Details - K781230

510(k) Number K781230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1978
Decision Date September 07, 1978
Days to Decision 51 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
80d faster than avg
Panel avg: 131d · This submission: 51d
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 528
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K781230.
CONPHAR STOMACH TUBE-STERILE
K791269 · Conphar, Inc. · Aug 1979
NUTRIFLOW NASOGASTRIC FEEDING TUBE
K790612 · Biosearch Medical Products, Inc. · May 1979
FEEDING TUBE W/ LUBRICANT COATING
K790387 · Biosearch Medical Products, Inc. · Apr 1979
SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE
K760708 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976
SILASTIC PERCUTANEOUS GASTROINTEST. TUBE
K760945 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976