Cleared Traditional

K935781 - ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (FDA 510(k) Clearance)

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

K935781 · Sherwood Medical Co. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
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.

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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
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.