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FDA 510(k)

UROGARD URINARY DRAINAGE BAG

K-Number: K771210 · 1977-07-11

ApplicantTerumo America, Inc.
Decision Date1977-07-11
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROGARD URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K771210. 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 UROGARD URINARY DRAINAGE BAG?

UROGARD URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Terumo America, Inc.. The 510(k) number is K771210.

When did UROGARD URINARY DRAINAGE BAG receive FDA 510(k) clearance?

UROGARD URINARY DRAINAGE BAG received FDA 510(k) clearance on 1977-07-11, under 510(k) number K771210.

Who is the listed applicant for UROGARD URINARY DRAINAGE BAG?

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

What is the FDA product code for UROGARD URINARY DRAINAGE BAG?

The FDA product code for UROGARD URINARY DRAINAGE BAG is FCN.

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Other records listing Terumo America, 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.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK801194CLIRANS TE07 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZER

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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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