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510(k) K964899

KENDALL CURITY URETERAL CATHETER by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code EYB

K964899 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "KENDALL CURITY URETERAL CATHETER". The FDA issued a decision of Substantially Equivalent on February 7, 1997. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Kendall Healthcare Products Co. Div.Of Tyco Health has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1997
Date Received
December 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

  • K973763 — KENDALL CURITY IODOFORM PACKING STRIP (December 31, 1997)
  • K973511 — KENDALL CURITY PETROLATUM GAUZE (December 16, 1997)
  • K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (December 15, 1997)
  • K973619 — KENDALL CURITY NON-ADHERING DRESSING (December 10, 1997)
  • K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (December 4, 1997)
  • K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (November 7, 1997)
  • K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING (April 23, 1997)
  • K963446 — KENDALL DUAL LUMEN CATHETER (March 18, 1997)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE (July 31, 1996)

Other clearances for product code EYB

  • K192183 — RocaTub Ureteral Catheter (April 23, 2020)
  • K191187 — Dornier MINNOW Ureteral Catheter (September 18, 2019)
  • K183323 — UPJ Occlusion Balloon Catheter (August 5, 2019)
  • K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (June 17, 2019)
  • K182122 — Ureteric Catheters (October 4, 2018)
  • K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cathet (September 14, 2018)
  • K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric C (December 21, 2017)
  • K133750 — OCCLUDER OCCLUSION BALLOON CATHETER (January 8, 2014)
  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
  • K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (March 3, 2009)

FDA data resources