Home / 510(k) Clearances / K192183

510(k) K192183

RocaTub Ureteral Catheter by Promepal Sam — Product Code EYB

K192183 is an FDA 510(k) premarket notification submitted by Promepal Sam for the device "RocaTub Ureteral Catheter". The FDA issued a decision of Substantially Equivalent on April 23, 2020. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2020
Date Received
August 12, 2019
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 for product code EYB

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

FDA data resources