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FDA 510(k)

BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG

K-Number: K890096 · 1989-07-14

ApplicantMedical Inventors Corp., Inc.
Decision Date1989-07-14
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG is the device name listed in this FDA 510(k) record. The listed applicant is Medical Inventors Corp., Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K890096. The device is classified under product code FCN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG?

BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Medical Inventors Corp., Inc.. The 510(k) number is K890096.

When did BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG receive FDA 510(k) clearance?

BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG received FDA 510(k) clearance on 1989-07-14, under 510(k) number K890096.

Who is the listed applicant for BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG?

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

What is the FDA product code for BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG?

The FDA product code for BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG is FCN.

Related Clinical Trials

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.

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Other records listing Medical Inventors Corp., 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.

K915166MICROCYCLER

Related Devices (Code: FCN)

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.

K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.K945258CATCO URINARY COLLECTION KITCatco Medical, Inc.K915166MICROCYCLERMedical Inventors Corp., Inc.K922346FEMALE URINE SAMPLING DEVICEMentor Corp.K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.K883610LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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