510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941781Substantially Equivalent

Rigiscan Plus Rigidity Assessment System

Dacomed Corp., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941781 is the FDA 510(k) clearance record for RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM, cleared for Dacomed Corp. on under FDA product code LIL (Monitor, Penile Tumescence). FDA records list 20 510(k) clearances for Dacomed Corp., from to . As of , FDA records show no recalls naming K941781.

Clearance record

Decision date
Received
(136 days to decision)
Product code
LIL Monitor, Penile Tumescence
Device class
Unclassified
Review panel
Unknown
Applicant
Dacomed Corp. 1701 E. 79th St., Suite 17, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code LIL

Trailing 12 months

FDA records hold no clearances under product code LIL in the trailing twelve months.

FDA records show no clearances under product code LIL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260