Ureteral Catheter

FDA 510(k) K930483 · Surgitek

Unknown

510(k) numberK930483

Submission

Device name
Ureteral Catheter
Applicant
Surgitek
Racine, WI, US
Received
January 29, 1993
Decision date
July 16, 1993
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EYB – Catheter, Ureteral, Gastro-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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K183323UPJ Occlusion Balloon CatheterEYB · Traditional Cook Incorporated08/05/2019SESK
K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB · Traditional Cook Incorporated06/17/2019SESK
K182122Ureteric CathetersEYB · Traditional Coloplast Corp.10/04/2018SE
K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterEYB · Traditional Cook Incorporated09/14/2018SE
K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB · Traditional Coloplast Corp.12/21/2017SE
K133750Occluder Occlusion Balloon CatheterEYB · Traditional Boston Scientific Corporation01/08/2014SE
K092250Medline Red Rubber Urethral CatheterEYB · Traditional Medline Industries, Inc.01/21/2010SE
K083788Endo Optiks Urological Catheter for Endoscopy, Model SessrEYB · Traditional Endooptiks, Inc.03/03/2009SE

More from Endooptiks, Inc.

510(k)DeviceDecision
K946296Quadra-Coil Ureteral StentFAD · Traditional 03/06/1995SE
K944391OM-4 (Tenative) Urodynamic Measruement SystemFEN · Traditional 02/07/1995SE
K943491Right Angle Urologic Laser FiberGEX · Traditional 08/05/1994SE
K941952Surgitek InfuserFAD · Traditional 05/24/1994SE
K933261Grasping ForcepsFGO · Traditional 01/11/1994SE
K933260Helical Stone/Flatwire Stone BasketsFFL · Traditional 01/11/1994SE
K930733Ureteral StentFAD · Traditional 07/23/1993SE
K926344Hydrophilic Coated GuidewireKNY · Traditional 03/05/1993SE
K920451Endotek Ultra SystemFAP · Traditional 09/17/1992SE
K922542Grasping ForcepsFGO · Traditional 08/19/1992SE

Questions and answers

When was Ureteral Catheter cleared by the FDA?

Ureteral Catheter (K930483) received a 510(k) decision of Unknown on July 16, 1993, 168 days after the submission was received.

What is the product code of K930483?

The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.