Home / 510(k) Clearances / K083788

510(k) K083788

ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR by Endooptiks, Inc. — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2009
Date Received
December 19, 2008
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 Endooptiks, Inc.

  • K042918 — MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 (November 22, 2004)
  • K003151 — MICROPOBE SERIES OF LASERS AND ACCESSORIES (January 8, 2001)
  • K945081 — TRANSTYMPANIC ENDOSCOPE (March 6, 1995)
  • K922917 — ENDOPROBES (September 28, 1992)

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