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FDA 510(k)

NIGHT URINARY DRAINAGE BEDSIDE BAG

K-Number: K930556 · 1993-05-14

ApplicantEzmt Valve Co., Inc.
Decision Date1993-05-14
Product CodeEYZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIGHT URINARY DRAINAGE BEDSIDE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Ezmt Valve Co., Inc.. It received FDA 510(k) clearance on 1993-05-14 under 510(k) number K930556. 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 NIGHT URINARY DRAINAGE BEDSIDE BAG?

NIGHT URINARY DRAINAGE BEDSIDE BAG is a medical device that received FDA 510(k) clearance on 1993-05-14. The listed applicant is Ezmt Valve Co., Inc.. The 510(k) number is K930556.

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

NIGHT URINARY DRAINAGE BEDSIDE BAG received FDA 510(k) clearance on 1993-05-14, under 510(k) number K930556.

Who is the listed applicant for NIGHT URINARY DRAINAGE BEDSIDE BAG?

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

What is the FDA product code for NIGHT URINARY DRAINAGE BEDSIDE BAG?

The FDA product code for NIGHT URINARY DRAINAGE BEDSIDE BAG is EYZ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ezmt Valve Co., 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.

K930557LATEX EXAMINATION GLOVEK913155LEG URINAL

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

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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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