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510(k) K923436

ILLUMINATED URETERAL CATHETER by Cook Urological, Inc. — Product Code FCS

K923436 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "ILLUMINATED URETERAL CATHETER". The FDA issued a decision of Substantially Equivalent on March 5, 1993. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1993
Date Received
July 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class
Class II
Regulation Number
876.4020
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 FCS

  • K151243 — STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral (August 20, 2015)
  • K061548 — STRYKER URETERAL ILLUMINATION SYSTEM IV (September 28, 2006)
  • K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM III (September 22, 1998)
  • K943801 — URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (August 15, 1995)
  • K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II (February 7, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 1994)
  • K940019 — GABRIEL URETERAL ILLUMINATOR SYSTEM (May 2, 1994)
  • K874680 — LASEGUIDE 600A, 600B, 400A, AND 400B (March 23, 1988)
  • K880071 — SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE (March 22, 1988)

FDA data resources