RocaTub Ureteral Catheter— 510(k) K192183

Substantially Equivalent

Promepal Sam

FDA 510(k) clearance K192183 for RocaTub Ureteral Catheter, Substantially Equivalent on 2020-04-23. Applicant: Promepal Sam. Device class: 2.

Clearance details

Applicant: Promepal Sam
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2019-08-12
Decision date: 2020-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYB

K191187 — Dornier MINNOW Ureteral Catheter2019-09-18
K183323 — UPJ Occlusion Balloon Catheter2019-08-05
K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter2019-06-17
K182122 — Ureteric Catheters2018-10-04
K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter2018-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.