Cutinova Cavity
FDA 510(k) K952526 · Beiersdorf, Inc.
510(k) numberK952526
Submission
- Device name
- Cutinova Cavity
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- June 1, 1995
- Decision date
- August 14, 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
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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 |
| 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 |
|---|---|---|
| K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…DWL · Traditional | 12/18/2009SE |
| K032463 | Curad Silver BandageFRO · Traditional | 02/10/2004SE |
| K032462 | Curad Silver Active Gel BandageFRO · Traditional | 02/10/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | 06/18/2003SE |
| K022645 | CuradKMF · Traditional | 11/05/2002SE |
| K943363 | Cutiplast SterilMGP · Traditional | 03/15/1995SE |
| K944581 | Cutinova Thin Wound DressingKMF · Traditional | 12/02/1994SN |
| K935630 | NortaEZL · Traditional | 10/07/1994SE |
| K940378 | Coverlet Adhesive DressingKGX · Traditional | 07/29/1994SN |
| K925630 | Elastoplast Heat PlasterIRT · Traditional | 02/25/1994SE |
Questions and answers
When was Cutinova Cavity cleared by the FDA?
Cutinova Cavity (K952526) received a 510(k) decision of Substantially Equivalent for Some Indications on August 14, 1995, 74 days after the submission was received.
What is the product code of K952526?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.