Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ESTEEM INCONTINENT SYSTEM

K-Number: K852276 · 1985-08-07

ApplicantBevan Medical, Inc.
Decision Date1985-08-07
Product CodeEYQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESTEEM INCONTINENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bevan Medical, Inc.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K852276. 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 ESTEEM INCONTINENT SYSTEM?

ESTEEM INCONTINENT SYSTEM is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Bevan Medical, Inc.. The 510(k) number is K852276.

When did ESTEEM INCONTINENT SYSTEM receive FDA 510(k) clearance?

ESTEEM INCONTINENT SYSTEM received FDA 510(k) clearance on 1985-08-07, under 510(k) number K852276.

Who is the listed applicant for ESTEEM INCONTINENT SYSTEM?

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

What is the FDA product code for ESTEEM INCONTINENT SYSTEM?

The FDA product code for ESTEEM INCONTINENT 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 Bevan Medical, 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.

K860459UNITY DISPOSABLE INCONTINENT BRIEF

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.

K950784DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEMAdvanced Bioresearch Assoc.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.

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.

↑