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510(k) K974040

C3 EXTERNAL MALE BLADDER CONTROL DEVICE by Timm Research Co. — Product Code FHA

K974040 is an FDA 510(k) premarket notification submitted by Timm Research Co. for the device "C3 EXTERNAL MALE BLADDER CONTROL DEVICE". The FDA issued a decision of Substantially Equivalent on July 14, 1998. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1998
Date Received
October 24, 1997
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 for product code FHA

  • 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)
  • K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE (February 8, 1989)
  • K863227 — COOK-VPI CONTINENCE CUFF (February 3, 1987)
  • K780137 — CLAMP, INCONTINENCE, BAUMRUCKER (April 28, 1978)

FDA data resources