Dignity Pant & Absorbent Pads
FDA 510(k) K850154 · Convatec, A Division of E.R. Squibb & Sons
510(k) numberK850154
Submission
- Device name
- Dignity Pant & Absorbent Pads
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
Princeton, NJ, US - Received
- January 15, 1985
- Decision date
- February 14, 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 |
|---|---|---|
| K090254 | Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)FRO · Traditional | 09/04/2009SE |
| K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingFRO · Traditional | 05/02/2008SE |
| K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…FRO · Traditional | 04/16/2007SE |
| K013814 | Absorbent Antimicrobial Wound DressingFRO · Traditional | 06/21/2002SE |
| K990964 | Signadress Duoderm DressingKGN · Traditional | 05/18/1999SE |
| K984388 | Ha Absorbent Wound DressingKGN · Traditional | 03/03/1999SE |
| K980720 | Nonwoven PadKMF · Traditional | 04/15/1998SE |
| K980382 | Non-Woven CompressKMF · Traditional | 03/09/1998SN |
| K974823 | Nonwoven DressingKMF · Traditional | 02/20/1998SN |
| K974205 | Knitted Wound Dressing-Standard, WCL and RibbonKMF · Traditional | 02/06/1998SE |
Questions and answers
When was Dignity Pant & Absorbent Pads cleared by the FDA?
Dignity Pant & Absorbent Pads (K850154) received a 510(k) decision of Substantially Equivalent on February 14, 1985, 30 days after the submission was received.
What is the product code of K850154?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.