Cleared Traditional

K935781 - ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALV...

K935781 is the FDA 510(k) clearance for ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALV... by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code FEG) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K935781 · Sherwood Medical Co. · Gastroenterology & Urology device
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Jan 1995
Decision
417d
Days
Class 2
Risk

K935781 is an FDA 510(k) clearance for the ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY. Classified as Tube, Double Lumen For Intestinal Decompression And/or Intubation (product code FEG), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K935781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 06, 1993
Decision Date January 27, 1995
Days to Decision 417 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 130d · This submission: 417d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation
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 - FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation

Devices cleared under the same product code (FEG) and FDA review panel - the closest regulatory comparables to K935781.
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · Cook Ireland, Ltd. · Aug 2017
MEDLINE ANTI-REFLUX VALVE
K132314 · Medline Industries, Inc. · Sep 2013
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K960176 · C.R. Bard, Inc. · Jul 1996
LOPEZ VALVE WITH NG SUMP TUBE
K921104 · Icu Medical, Inc. · Oct 1992
WILSON-COOK COLON DECOMPRESSION SET
K900035 · Wilson-Cook Medical, Inc. · Mar 1990
HODGE TUBE
K772282 · Mallinckrodt Critical Care · Mar 1978