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510(k) K182122

Ureteric Catheters by Coloplast Corp. — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2018
Date Received
August 6, 2018
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 Coloplast Corp.

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  • K251116 — Luja Coudé (June 27, 2025)
  • K250270 — Luja Set (April 17, 2025)
  • K242049 — SureCath Set (November 26, 2024)
  • K241210 — Luja Coude (November 21, 2024)
  • K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, (November 12, 2024)
  • K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
  • K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (2005 (July 26, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - (March 22, 2024)

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)
  • 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)
  • K043581 — DUAL LUMEN CATHETER (March 3, 2005)