Cleared Traditional

K841202 - DACOMED RIGISCAN SYSTEM

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.

View all Dacomed Corp. devices

FDA 510(k) Submission Details - K841202

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 131d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

All 12
Devices cleared under the same product code (LIL) and FDA review panel - the closest regulatory comparables to K841202.
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
K941781 · Dacomed Corp. · Aug 1994
BARD (R) ESKA ERECTIOMETER
K880903 · C.R. Bard, Inc. · May 1988
SURGITEK NPT MONITOR
K875333 · Surgitek · Apr 1988
DACOMED SNAP-GAUGE
K832121 · Dacomed Corp. · Jul 1983
TUMISENSOR 1524
K831251 · Life-Tech Intl., Inc. · Jun 1983
TUMISTORE RECORDER 1311
K831252 · Life-Tech Intl., Inc. · May 1983