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510(k) K820615

DACOMED SNAP-GAUGE by Dacomed Corp. — Product Code LIL

K820615 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DACOMED SNAP-GAUGE". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Dacomed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
March 8, 1982
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 by Dacomed Corp.

  • K953640 — DUNA II PENILE PROSTHESIS (October 27, 1995)
  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • K920409 — DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE (May 11, 1992)
  • K920420 — DURA II PENILE PROSTHESIS (April 16, 1992)
  • K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (October 11, 1991)
  • K900774 — DACOMED NEGATIVE PRESSURE ERECTION DEVICE (May 4, 1990)
  • K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE (February 8, 1989)
  • K880391 — DACOMED CYSTOMETER (April 27, 1988)
  • K871653 — DURAPHASE PENILE PROSTHESIS (September 18, 1987)
  • K870320 — DACOMED PENILE PROSTHESIS SIZER (March 17, 1987)

Other clearances for product code LIL

  • K061676 — RIGIDOMETER, MODEL DIR-4U (December 27, 2006)
  • 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)

FDA data resources