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FDA 510(k)

URINE SPECIMEN COLLECTING DEVICE

K-Number: K772133 · 1977-11-28

ApplicantKendall Research Center
Decision Date1977-11-28
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINE SPECIMEN COLLECTING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Research Center. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772133. 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 URINE SPECIMEN COLLECTING DEVICE?

URINE SPECIMEN COLLECTING DEVICE is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Kendall Research Center. The 510(k) number is K772133.

When did URINE SPECIMEN COLLECTING DEVICE receive FDA 510(k) clearance?

URINE SPECIMEN COLLECTING DEVICE received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772133.

Who is the listed applicant for URINE SPECIMEN COLLECTING DEVICE?

The FDA 510(k) record lists Kendall Research Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINE SPECIMEN COLLECTING DEVICE?

The FDA product code for URINE SPECIMEN COLLECTING DEVICE is FCN.

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Other records listing Kendall Research Center 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.

K802225TENDER-SORB DRAIN SPONGESK781357T.E.D. SEQUENTIAL COMPRESSION SLEEVESK780408MICRONET LIGHT DRESSING SPONGEK780062CATHETER/HEMOSTATIC/GERIATRICK780120ANESTHESIA TRAY, CAUDALK772134SYRINGE, IRRIGATION, PRE-FILLED

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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.K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, 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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