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510(k) K896160

WILLIAMS PENILE ANESTHETIC RETAINER by Cook Urological, Inc. — Product Code FHA

K896160 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "WILLIAMS PENILE ANESTHETIC RETAINER". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
October 24, 1989
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 Cook Urological, Inc.

  • K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (May 6, 2011)
  • K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER (October 9, 2009)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (November 7, 2008)
  • K082536 — COOK WIRE GUIDES (October 27, 2008)
  • K082319 — INJEKT FILIFORM INJECTION NEEDLE (September 25, 2008)
  • K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (April 17, 2008)
  • K073496 — OPTILITE HOLMIUM LASER FIBERS (January 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (August 17, 2006)

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)
  • 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