Allevyn Tracheostomy Dressing
FDA 510(k) K890748 · Smith & Nephew United, Inc.
510(k) numberK890748
Submission
- Device name
- Allevyn Tracheostomy Dressing
- Applicant
- Smith & Nephew United, Inc.
Largo, FL, US - Received
- February 13, 1989
- Decision date
- March 8, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K963096 | Allevyn Hydro Poly Dressing ND All Trac DressingKMF · Traditional | 10/25/1996SE |
| K961775 | Profore Four-Layer Bandage System KitEFQ · Traditional | 07/16/1996SE |
| K945330 | Allevyn AdhesiveKMF · Traditional | 02/09/1995SN |
| K943619 | Cavi-Care Conforming Foam DressingKMF · Traditional | 08/19/1994SN |
| K942748 | IntrasiteNAE · Traditional | 06/29/1994SN |
| K935705 | Allevyn Island Wound DressingNAE · Traditional | 02/15/1994SE |
| K935803 | Cica-Care Silicone Gel SheetMDA · Traditional | 02/03/1994SE |
| K932263 | Solosite Dermal Wound GelMGQ · Traditional | 10/01/1993SE |
| K926508 | Intrasite GelNAE · Traditional | 07/13/1993SE |
| K922897 | StrappalKGX · Traditional | 09/15/1992SE |
Questions and answers
When was Allevyn Tracheostomy Dressing cleared by the FDA?
Allevyn Tracheostomy Dressing (K890748) received a 510(k) decision of Substantially Equivalent for Some Indications on March 8, 1989, 23 days after the submission was received.
What is the product code of K890748?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.