Cleared Traditional

K911897 - GASPARAITIS ESOPHAGRAM CATHETER SET

K911897 is an FDA 510(k) clearance for GASPARAITIS ESOPHAGRAM CATHETER SET, manufactured by E-Z-Em, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K911897 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Jul 1991
Decision
86d
Days
Class 2
Risk

K911897 is an FDA 510(k) clearance for the GASPARAITIS ESOPHAGRAM CATHETER SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Worcester, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 86 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 - K911897

510(k) Number K911897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date July 24, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 131d · This submission: 86d
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 651
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K911897.
FIBRETWINS
K913603 · Oral-B Laboratories · Sep 1991
WILSON-COOK RUSSELL GASTROSTOMY KIT
K912047 · Wilson-Cook Medical, Inc. · Sep 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382 · Abbott Laboratories · Aug 1991
MOSS- ANCHOR SET
K910910 · Moss Medical Products · Jun 1991
MOSS NASAL TUBE MARK IV
K910912 · Moss Medical Products · May 1991
MOSS P.E.G. TRAY
K910911 · Moss Medical Products · May 1991
K911897 · GASPARAITIS ESOPHAGRAM CATHETER SET
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