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510(k) K892855

URETHRAL BALLOON DILATION CATHETER SET by Cook Urological, Inc. — Product Code KOE

K892855 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "URETHRAL BALLOON DILATION CATHETER SET". The FDA issued a decision of Substantially Equivalent on November 17, 1989. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1989
Date Received
April 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
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 KOE

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)

FDA data resources