Cleared Traditional

URISTOP (K803109) - FDA 510(k) Clearance

K803109 · The Sora Co. · Gastroenterology & Urology device
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Feb 1981
Decision
77d
Days
-
Risk

K803109 is an FDA 510(k) clearance for the URISTOP.

Submitted by The Sora Co. (Mchenry, US). The FDA issued a Cleared decision on February 25, 1981 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K803109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1980
Decision Date February 25, 1981
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -