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510(k) K883119

VPI NON-ADHESIVE CONDOM CATHETER by Cook Urological, Inc. — Product Code EYT

K883119 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "VPI NON-ADHESIVE CONDOM CATHETER". The FDA issued a decision of Substantially Equivalent on August 2, 1988. The device falls under product code EYT (Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1988
Date Received
July 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
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 EYT

  • K934080 — URINARY DRAINAGE BAG (May 18, 1994)
  • K935774 — CURITY FAST-CATH FEMALE CATHETER KIT (April 11, 1994)
  • K883057 — COMFORT CATH MALE EXTERNAL CATHETER (August 2, 1988)

FDA data resources