Cleared Traditional

DACOMED RIGISCAN SYSTEM (K841202) - FDA 510(k) Clearance

K841202 · Dacomed Corp. · Gastroenterology & Urology device
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Jul 1984
Decision
107d
Days
-
Risk

K841202 is an FDA 510(k) clearance for the DACOMED RIGISCAN SYSTEM. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Dacomed Corp. (Walker, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 107 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 K841202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1984
Decision Date July 06, 1984
Days to Decision 107 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
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -