Cleared Traditional

K841350 - SALIVARY BYPASS TUBE (FDA 510(k) Clearance)

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.

View all E. Benson Hood Laboratories, Inc. devices

Submission Details

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
15d faster than avg
Panel avg: 130d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -