Cleared Traditional

ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT (K840752) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840752 · E-Z-Em, Inc. · Gastroenterology & Urology device
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May 1984
Decision
69d
Days
Class 2
Risk

K840752 is an FDA 510(k) clearance for the ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Walker, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 69 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K840752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date May 02, 1984
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
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 124
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K840752.
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · Abbott Laboratories · Oct 1983
STOMACH TUBE LEVIN TUBE
K831974 · Medline Industries, Inc. · Jul 1983
ARGYLE MADEN SILICONE GASTROSTOMY TUBE
K830794 · Sherwood Medical Co. · May 1983