Cleared Traditional

K832196 - SHERIDAN/LEVI-A-SUMP

K832196 is the FDA 510(k) clearance for SHERIDAN/LEVI-A-SUMP by Sheridan Catheter Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K832196 · Sheridan Catheter Corp. · Gastroenterology & Urology device
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Oct 1983
Decision
99d
Days
Class 2
Risk

K832196 is an FDA 510(k) clearance for the SHERIDAN/LEVI-A-SUMP. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sheridan Catheter Corp. devices

Submission Details

510(k) Number K832196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1983
Decision Date October 14, 1983
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
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 206
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K832196.
ENTRI FLEX FEEDING TUBE
K833621 · Biosearch Medical Products, Inc. · Nov 1983
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · Abbott Laboratories · Oct 1983
LEIDER FEEDING TUBE W/HYDROMER LUBR
K833293 · Biosearch Medical Products, Inc. · Oct 1983
ENTERNAL FEEDING TUBE
K832293 · Concept, Inc. · Sep 1983
FEEDING TUBE PLACEMENT STYLET
K831840 · Biosearch Medical Products, Inc. · Aug 1983
STOMACH TUBE LEVIN TUBE
K831974 · Medline Industries, Inc. · Jul 1983