Cleared Traditional

K841350 - SALIVARY BYPASS TUBE

K841350 · E. Benson Hood Laboratories, Inc. · Gastroenterology & Urology device
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Jul 1984
Decision
115d
Days
-
Risk

K841350 is an FDA 510(k) clearance for the SALIVARY BYPASS TUBE.

Submitted by E. Benson Hood Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1984 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. 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.

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FDA 510(k) Submission Details - K841350

510(k) Number K841350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date July 26, 1984
Days to Decision 115 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
16d faster than avg
Panel avg: 131d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -