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FDA 510(k)

NEPHRO-URETERAL STENT

K-Number: K942688 · 1995-06-06

ApplicantUresil Corp.
Decision Date1995-06-06
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

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 1995-06-06 under 510(k) number K942688. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHRO-URETERAL STENT?

NEPHRO-URETERAL STENT is a medical device that received FDA 510(k) clearance on 1995-06-06. The listed applicant is Uresil Corp.. The 510(k) number is K942688.

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

NEPHRO-URETERAL STENT received FDA 510(k) clearance on 1995-06-06, under 510(k) number K942688.

Who is the listed applicant for 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 NEPHRO-URETERAL STENT?

The FDA product code for 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 MARKERK980889URESIL NEPHRO-URETERAL STENTK972582URESIL GUIDEWIRE

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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.

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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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