Cleared Traditional

K823075 - REXTON (FDA 510(k) Clearance)

K823075 · Argosy Intl. (Usa), Inc. · Gastroenterology & Urology device
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Nov 1982
Decision
20d
Days
-
Risk

K823075 is an FDA 510(k) clearance for the REXTON.

Submitted by Argosy Intl. (Usa), Inc. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1982 after a review of 20 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.

View all Argosy Intl. (Usa), Inc. devices

Submission Details

510(k) Number K823075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date November 08, 1982
Days to Decision 20 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
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -