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FDA 510(k)

URETHRAL AND URETERAL BALLOON DILATATORS

K-Number: K884711 · 1989-09-29

ApplicantPrimrose Medical, Inc.
Decision Date1989-09-29
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL AND URETERAL BALLOON DILATATORS is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1989-09-29 under 510(k) number K884711. 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 URETHRAL AND URETERAL BALLOON DILATATORS?

URETHRAL AND URETERAL BALLOON DILATATORS is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K884711.

When did URETHRAL AND URETERAL BALLOON DILATATORS receive FDA 510(k) clearance?

URETHRAL AND URETERAL BALLOON DILATATORS received FDA 510(k) clearance on 1989-09-29, under 510(k) number K884711.

Who is the listed applicant for URETHRAL AND URETERAL BALLOON DILATATORS?

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

What is the FDA product code for URETHRAL AND URETERAL BALLOON DILATATORS?

The FDA product code for URETHRAL AND URETERAL BALLOON DILATATORS is EZN.

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Other records listing Primrose Medical, 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.

K884714BILIARY DIALATORK884715ACHELASIA BALLOON DIALATORK884713COLONIC BALLOON DIALATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)K883420LANCET, BLOOD

View all 14 devices →

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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