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FDA 510(k)

URETERAL DILATOR

K-Number: K852324 · 1985-08-21

ApplicantAmerican Edwards Laboratories
Decision Date1985-08-21
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852324. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETERAL DILATOR?

URETERAL DILATOR is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is American Edwards Laboratories. The 510(k) number is K852324.

When did URETERAL DILATOR receive FDA 510(k) clearance?

URETERAL DILATOR received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852324.

Who is the listed applicant for URETERAL DILATOR?

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

What is the FDA product code for URETERAL DILATOR?

The FDA product code for URETERAL DILATOR is EZN.

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Other records listing American Edwards Laboratories as applicant

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Related Devices (Code: EZN)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook 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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