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FDA 510(k)

ACCENT DG BALLOON URETERAL DILATOR SET

K-Number: K905375 · 1991-04-12

ApplicantCook Urological, Inc.
Decision Date1991-04-12
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACCENT DG BALLOON URETERAL DILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K905375. 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 ACCENT DG BALLOON URETERAL DILATOR SET?

ACCENT DG BALLOON URETERAL DILATOR SET is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Cook Urological, Inc.. The 510(k) number is K905375.

When did ACCENT DG BALLOON URETERAL DILATOR SET receive FDA 510(k) clearance?

ACCENT DG BALLOON URETERAL DILATOR SET received FDA 510(k) clearance on 1991-04-12, under 510(k) number K905375.

Who is the listed applicant for ACCENT DG BALLOON URETERAL DILATOR SET?

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

What is the FDA product code for ACCENT DG BALLOON URETERAL DILATOR SET?

The FDA product code for ACCENT DG BALLOON URETERAL DILATOR SET is EZN.

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Other records listing Cook Urological, Inc. 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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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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