Cleared Traditional

K833690 - COAXIAL BALLOON URETHRAL DILATOR (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K833690 · American Edwards Laboratories · Gastroenterology & Urology device
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Nov 1983
Decision
42d
Days
Class 3
Risk

K833690 is an FDA 510(k) clearance for the COAXIAL BALLOON URETHRAL DILATOR. Classified as Replacer, Urethral (product code FAA), Class III - Premarket Approval.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 42 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: High-complexity regulatory submission. High regulatory complexity profile. 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 K833690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date November 29, 1983
Days to Decision 42 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
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FAA Replacer, Urethral
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.