Allevyn Adhesive
FDA 510(k) K945330 · Smith & Nephew United, Inc.
510(k) numberK945330
Submission
- Device name
- Allevyn Adhesive
- Applicant
- Smith & Nephew United, Inc.
Largo, FL, US - Received
- November 1, 1994
- Decision date
- February 9, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
Other 510(k)s with product code KMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin ProtectantKMF · Traditional | Optmed, Inc. | 09/27/2024SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | Rochal Industries, LLC | 06/27/2019SE |
| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 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 |
| 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 |
| K914147 | Allevlyn Wound Dressing, ModificationKMF · Traditional | 02/03/1992SE |
Questions and answers
When was Allevyn Adhesive cleared by the FDA?
Allevyn Adhesive (K945330) received a 510(k) decision of Substantially Equivalent for Some Indications on February 9, 1995, 100 days after the submission was received.
What is the product code of K945330?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.