Cavilon Advanced High Endurance Skin Protectant
FDA 510(k) K153571 · 3M Healthcare
510(k) numberK153571
Submission
- Device name
- Cavilon Advanced High Endurance Skin Protectant
- Applicant
- 3M Healthcare
St. Paul, MN, US - Received
- December 15, 2015
- Decision date
- August 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
| K083913 | Chesson Labs Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 07/31/2009SE |
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| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 08/18/2014SE |
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| K974445 | 3M Red Dot Resting EKG Electrode, Catalog 2360DRX · Traditional | 07/26/1998SE |
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Questions and answers
When was Cavilon Advanced High Endurance Skin Protectant cleared by the FDA?
Cavilon Advanced High Endurance Skin Protectant (K153571) received a 510(k) decision of Substantially Equivalent on August 23, 2016, 252 days after the submission was received.
What is the product code of K153571?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.