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510(k) K885323

DACOMED EXTERNAL MALE CONTINENCE DEVICE by Dacomed Corp. — Product Code FHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1989
Date Received
December 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Penile
Device Class
Class I
Regulation Number
876.5160
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)
  • 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 FHA

  • K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE (July 14, 1998)
  • K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (August 1, 1997)
  • K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (April 2, 1997)
  • K964580 — CAP-AID (IMPROVED) (January 10, 1997)
  • K955810 — U-TEX (January 24, 1996)
  • K954959 — CAP-AID (December 6, 1995)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K896160 — WILLIAMS PENILE ANESTHETIC RETAINER (February 16, 1990)
  • K863227 — COOK-VPI CONTINENCE CUFF (February 3, 1987)
  • K780137 — CLAMP, INCONTINENCE, BAUMRUCKER (April 28, 1978)