Cleared Traditional

RIGIDOMETER, MODEL DIR-4U (K061676) - FDA 510(k) Clearance

K061676 · Uroan 21 · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
196d
Days
-
Risk

K061676 is an FDA 510(k) clearance for the RIGIDOMETER, MODEL DIR-4U. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Uroan 21 (Palma De Mallorca, ES). The FDA issued a Cleared decision on December 27, 2006 after a review of 196 days - an extended review 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: 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 K061676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2006
Decision Date December 27, 2006
Days to Decision 196 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 130d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -