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510(k) K920409

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE by Dacomed Corp. — Product Code LKY

K920409 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE". The FDA issued a decision of Substantially Equivalent on May 11, 1992. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Dacomed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1992
Date Received
January 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, External Penile Rigidity
Device Class
Class II
Regulation Number
876.5020
Review Panel
GU
Submission Type

Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.

Other clearances by Dacomed Corp.

  • K953640 — DUNA II PENILE PROSTHESIS (October 27, 1995)
  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • 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)
  • K854118 — DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS (March 17, 1986)

Other clearances for product code LKY

  • K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (August 25, 2004)
  • K032776 — VACURECT VACUUM CONSTRICTION DEVICE (October 3, 2003)
  • K030119 — NANMA ADJUSTABLE CONSTRICTION RING (August 6, 2003)
  • K030913 — NANMA VACUUM PUMP (June 3, 2003)
  • K013113 — MODIFICATION TO NANMA VACUUM PUMP (December 20, 2002)
  • K013051 — NANMA ADJUSTABLE CONSTRICTION RING (August 22, 2002)
  • K020969 — VACURECT VACUUM CONSTRICTION DEVICE (June 5, 2002)
  • K013053 — MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (May 9, 2002)
  • K020154 — VT-1 (April 4, 2002)
  • K020258 — SUPPORT SLEEVE (April 4, 2002)

FDA data resources