Cleared Traditional

NEPHROSS 11F100 (K790352) - FDA 510(k) Clearance

K790352 · Redy Laboratories · Gastroenterology & Urology device
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Feb 1979
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K790352 is an FDA 510(k) clearance for the NEPHROSS 11F100.

Submitted by Redy Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 22, 1979.

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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Submission Details

510(k) Number K790352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received February 22, 1979
Decision Date February 22, 1979
Days to Decision -
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -