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FDA 510(k)

DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM

K-Number: K950784 · 1995-05-03

ApplicantAdvanced Bioresearch Assoc.
Decision Date1995-05-03
Product CodeEYQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bioresearch Assoc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K950784. The device is classified under product code EYQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM?

DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Advanced Bioresearch Assoc.. The 510(k) number is K950784.

When did DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM received FDA 510(k) clearance on 1995-05-03, under 510(k) number K950784.

Who is the listed applicant for DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM?

The FDA 510(k) record lists Advanced Bioresearch Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM?

The FDA product code for DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM is EYQ.

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 Advanced Bioresearch Assoc. 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.

K943695SURETEMPK944619I.V.I.D. FLUID ADMINISTRATION SET MARKER

Related Devices (Code: EYQ)

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.

K932310KIT PAK INCONTINENT SKIN CARE KITKit Pak, Inc.K903342DEODORIZING AND SOUND MUFFLING ANAL PADBiological Resistance, Inc.K891686LIB SYSTEM, BABY/ADULT DIAPERIntera Corp.K885185INTERA SHIELD AND INTERA UNDERGARMENTIntera Corp.K883894DRIPRIDE PROVIDE SLIMWeyerhaeuser Co.K883895DRIPRIDE ULTRA INCONTINENT PADWeyerhaeuser Co.

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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