Adult Absorbent Incontinent Brief
FDA 510(k) K854408 · Weyerhaeuser Co.
510(k) numberK854408
Submission
- Device name
- Adult Absorbent Incontinent Brief
- Applicant
- Weyerhaeuser Co.
Tacoma, WA, US - Received
- November 1, 1985
- Decision date
- November 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K950784 | Dristar Urinary Incontinence Management SystemEYQ · Traditional | Advanced Bioresearch Assoc. | 05/03/1995SE |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | Kit Pak, Inc. | 06/01/1994SEKD |
| K903342 | Deodorizing and Sound Muffling Anal PadEYQ · Traditional | Biological Resistance, Inc. | 10/23/1990SE |
| K891686 | Lib System, Baby/Adult DiaperEYQ · Traditional | Intera Corp. | 05/31/1989SE |
| K885185 | Intera Shield and Intera UndergarmentEYQ · Traditional | Intera Corp. | 02/08/1989SE |
| K883895 | Dripride Ultra Incontinent PadEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883894 | Dripride Provide SlimEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883787 | Reusable Adult Incontinent DiaperEYQ · Traditional | Intera Corp. | 11/07/1988SE |
| K882418 | Dry Comfort UndergarmentEYQ · Traditional | Health Tec, Inc. | 09/29/1988SE |
| K880454 | At Ease Stress PadEYQ · Traditional | Hospital Specialty Co. | 06/16/1988SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K883895 | Dripride Ultra Incontinent PadEYQ · Traditional | 01/30/1989SE |
| K883894 | Dripride Provide SlimEYQ · Traditional | 01/30/1989SE |
| K881859 | Dripride Disposable UnderpadKME · Traditional | 06/03/1988SE |
| K872059 | Dripride Provide UltraEYQ · Traditional | 03/16/1988SE |
| K871725 | Dripride Disposable UnderpadsKME · Traditional | 05/15/1987SE |
| K834359 | Absorbent Incontinent Pads & BriefsEYQ · Traditional | 03/05/1984SE |
| K831593 | Maxi ShieldsHHD · Traditional | 08/12/1983SE |
| K830224 | Unscented Panty ShieldsHHD · Traditional | 02/08/1983SE |
| K812577 | Unscented Menstrual PadsHHD · Traditional | 10/19/1981SE |
Questions and answers
When was Adult Absorbent Incontinent Brief cleared by the FDA?
Adult Absorbent Incontinent Brief (K854408) received a 510(k) decision of Substantially Equivalent on November 19, 1985, 18 days after the submission was received.
What is the product code of K854408?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.