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510(k) K061676

RIGIDOMETER, MODEL DIR-4U by Uroan 21 — Product Code LIL

K061676 is an FDA 510(k) premarket notification submitted by Uroan 21 for the device "RIGIDOMETER, MODEL DIR-4U". The FDA issued a decision of Substantially Equivalent on December 27, 2006. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2006
Date Received
June 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Penile Tumescence
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances for product code LIL

  • K062042 — PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (September 6, 2006)
  • K052929 — PREFTEST PROFESSIONAL SUITE (April 26, 2006)
  • K033126 — MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (October 29, 2003)
  • K000194 — DIGITAL INFLECTION RIGIDOMETER (DIR) (April 10, 2000)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K980627 — NEVA SYSTEM (April 7, 1998)
  • K940128 — CAT-400UL PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • K925931 — RT2 RIGIDITY AND TUMESCENCE TEST (December 21, 1992)

FDA data resources