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FDA 510(k)

AMCATH URETERAL DILATORS MODELS 7100,7110,7120

K-Number: K894925 · 1989-12-13

ApplicantIntec Medical, Inc.
Decision Date1989-12-13
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMCATH URETERAL DILATORS MODELS 7100,7110,7120 is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K894925. 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 AMCATH URETERAL DILATORS MODELS 7100,7110,7120?

AMCATH URETERAL DILATORS MODELS 7100,7110,7120 is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Intec Medical, Inc.. The 510(k) number is K894925.

When did AMCATH URETERAL DILATORS MODELS 7100,7110,7120 receive FDA 510(k) clearance?

AMCATH URETERAL DILATORS MODELS 7100,7110,7120 received FDA 510(k) clearance on 1989-12-13, under 510(k) number K894925.

Who is the listed applicant for AMCATH URETERAL DILATORS MODELS 7100,7110,7120?

The FDA 510(k) record lists Intec Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMCATH URETERAL DILATORS MODELS 7100,7110,7120?

The FDA product code for AMCATH URETERAL DILATORS MODELS 7100,7110,7120 is EZN.

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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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