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FDA 510(k)

CLOSED SYSTEM URINARY DRAINAGE BAG

K-Number: K890465 · 1989-05-23

ApplicantCypress Medical Products, Ltd.
Decision Date1989-05-23
Product CodeEYZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLOSED SYSTEM URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Cypress Medical Products, Ltd.. It received FDA 510(k) clearance on 1989-05-23 under 510(k) number K890465. The device is classified under product code EYZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOSED SYSTEM URINARY DRAINAGE BAG?

CLOSED SYSTEM URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Cypress Medical Products, Ltd.. The 510(k) number is K890465.

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

CLOSED SYSTEM URINARY DRAINAGE BAG received FDA 510(k) clearance on 1989-05-23, under 510(k) number K890465.

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

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

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

The FDA product code for CLOSED SYSTEM URINARY DRAINAGE BAG is EYZ.

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Other records listing Cypress Medical Products, Ltd. 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.

K021676CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METALK012282STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVEK972899CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETERK972849ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)K972883ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)K952367CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE

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Related Devices (Code: EYZ)

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.

K964219ZIP CONDOM CATHETERGoulter Medical, Inc.K961906UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.K952780URINARY GEL DRAINAGE SYSTEMP.A.M., Inc.K951597URINARY DRAINAGE BAGKey Medical Services, Inc.K942753ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERResearched, Novel Medical Devices (Rn/Md)K933126COMFORTCARE SYSTEMPatsy J. Trisler, J.D.

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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