Cleared Traditional

RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (K941781) - FDA 510(k) Clearance

K941781 · Dacomed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
136d
Days
-
Risk

K941781 is an FDA 510(k) clearance for the RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on August 25, 1994 after a review of 136 days - within the typical 510(k) review window.

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 K941781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date August 25, 1994
Days to Decision 136 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
6d slower than avg
Panel avg: 130d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -