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FDA 510(k)

URESIL SUMP DRAINAGE CATHETER

K-Number: K920509 · 1992-09-14

ApplicantUresil Corp.
Decision Date1992-09-14
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

URESIL SUMP DRAINAGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1992-09-14 under 510(k) number K920509. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL SUMP DRAINAGE CATHETER?

URESIL SUMP DRAINAGE CATHETER is a medical device that received FDA 510(k) clearance on 1992-09-14. The listed applicant is Uresil Corp.. The 510(k) number is K920509.

When did URESIL SUMP DRAINAGE CATHETER receive FDA 510(k) clearance?

URESIL SUMP DRAINAGE CATHETER received FDA 510(k) clearance on 1992-09-14, under 510(k) number K920509.

Who is the listed applicant for URESIL SUMP DRAINAGE CATHETER?

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 SUMP DRAINAGE CATHETER?

The FDA product code for URESIL SUMP DRAINAGE CATHETER 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)

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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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