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FDA 510(k)

URESIL NEPHRO-URETERAL STENT

K-Number: K980889 · 1998-04-08

ApplicantUresil Corp.
Decision Date1998-04-08
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

URESIL NEPHRO-URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1998-04-08 under 510(k) number K980889. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL NEPHRO-URETERAL STENT?

URESIL NEPHRO-URETERAL STENT is a medical device that received FDA 510(k) clearance on 1998-04-08. The listed applicant is Uresil Corp.. The 510(k) number is K980889.

When did URESIL NEPHRO-URETERAL STENT receive FDA 510(k) clearance?

URESIL NEPHRO-URETERAL STENT received FDA 510(k) clearance on 1998-04-08, under 510(k) number K980889.

Who is the listed applicant for URESIL NEPHRO-URETERAL STENT?

The FDA 510(k) record lists Uresil Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URESIL NEPHRO-URETERAL STENT?

The FDA product code for URESIL NEPHRO-URETERAL STENT is LJE.

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Other records listing Uresil Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHEK980278URESIL VASCU-FLO INFUSION CATHETERK981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATINGK980282URESIL DILATOR WITH RADIOPAQUE MARKERK972582URESIL GUIDEWIREK972583URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S

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Related Devices (Code: LJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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