Esteem Incontinent System

FDA 510(k) K852276 · Bevan Medical, Inc.

Substantially Equivalent

510(k) numberK852276

Submission

Device name
Esteem Incontinent System
Applicant
Bevan Medical, Inc.
Rexdale, CA
Received
May 29, 1985
Decision date
August 7, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EYQ – Garment, Protective, For Incontinence
Device class
Class I (low risk)
Regulation
21 CFR 876.5920
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EYQ

510(k)DeviceApplicantDecision
K950784Dristar Urinary Incontinence Management SystemEYQ · Traditional Advanced Bioresearch Assoc.05/03/1995SE
K932310Kit Pak Incontinent Skin Care KitEYQ · Traditional Kit Pak, Inc.06/01/1994SEKD
K903342Deodorizing and Sound Muffling Anal PadEYQ · Traditional Biological Resistance, Inc.10/23/1990SE
K891686Lib System, Baby/Adult DiaperEYQ · Traditional Intera Corp.05/31/1989SE
K885185Intera Shield and Intera UndergarmentEYQ · Traditional Intera Corp.02/08/1989SE
K883895Dripride Ultra Incontinent PadEYQ · Traditional Weyerhaeuser Co.01/30/1989SE
K883894Dripride Provide SlimEYQ · Traditional Weyerhaeuser Co.01/30/1989SE
K883787Reusable Adult Incontinent DiaperEYQ · Traditional Intera Corp.11/07/1988SE
K882418Dry Comfort UndergarmentEYQ · Traditional Health Tec, Inc.09/29/1988SE
K880454At Ease Stress PadEYQ · Traditional Hospital Specialty Co.06/16/1988SE

More from Hospital Specialty Co.

510(k)DeviceDecision
K860459Unity Disposable Incontinent BriefEYQ · Traditional 02/26/1986SE

Questions and answers

When was Esteem Incontinent System cleared by the FDA?

Esteem Incontinent System (K852276) received a 510(k) decision of Substantially Equivalent on August 7, 1985, 70 days after the submission was received.

What is the product code of K852276?

The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.