Atraum Wound Dressing--Modification
FDA 510(k) K922760 · Axiom Medical, Inc.
510(k) numberK922760
Submission
- Device name
- Atraum Wound Dressing--Modification
- Applicant
- Axiom Medical, Inc.
Paramount, CA, US - Received
- May 28, 1992
- Decision date
- October 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K993592 | Axiom Multipurpose Wound DrainBSO · Traditional | 05/17/2000SE |
| K971851 | Interpleural Anesthesia CatheterBSO · Traditional | 01/22/1998SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | 03/10/1997SE |
| K934895 | Glassman Silicone CatheterEZL · Traditional | 10/13/1994SE |
| K905422 | PVC Round Wound DrainsGBX · Traditional | 02/11/1991SE |
| K904218 | Suction SystemGEA · Traditional | 10/31/1990SE |
| K904133 | Disposable Fluid Collection BagGBX · Traditional | 10/11/1990SE |
| K863247 | Axiom Trocar Thoracic CatheterGBS · Traditional | 08/29/1986SE |
| K861306 | Suction SystemGEA · Traditional | 06/09/1986SE |
| K852614 | Atraum Wound DressingFRO · Traditional | 08/30/1985SE |
Questions and answers
When was Atraum Wound Dressing--Modification cleared by the FDA?
Atraum Wound Dressing--Modification (K922760) received a 510(k) decision of Substantially Equivalent on October 30, 1992, 155 days after the submission was received.
What is the product code of K922760?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.