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FDA 510(k)

DOUBLE CLOSED URINARY DRAINAGE SYSTEM

K-Number: K883886 · 1988-12-19

ApplicantKnight Medical, Inc.
Decision Date1988-12-19
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOUBLE CLOSED URINARY DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Knight Medical, Inc.. It received FDA 510(k) clearance on 1988-12-19 under 510(k) number K883886. 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 DOUBLE CLOSED URINARY DRAINAGE SYSTEM?

DOUBLE CLOSED URINARY DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-12-19. The listed applicant is Knight Medical, Inc.. The 510(k) number is K883886.

When did DOUBLE CLOSED URINARY DRAINAGE SYSTEM receive FDA 510(k) clearance?

DOUBLE CLOSED URINARY DRAINAGE SYSTEM received FDA 510(k) clearance on 1988-12-19, under 510(k) number K883886.

Who is the listed applicant for DOUBLE CLOSED URINARY DRAINAGE SYSTEM?

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

What is the FDA product code for DOUBLE CLOSED URINARY DRAINAGE SYSTEM?

The FDA product code for DOUBLE CLOSED URINARY DRAINAGE SYSTEM 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 Knight 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.

K921127PANDA NEEDLE CATHETER JEJUNOSTOMY KITK903086TUBE GASTROSTOMYK883848KMI OXY-BANK862489ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE

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.K890096BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.K883610LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.

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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