BeneHold Surgical Incise Drape with CHG antimicrobial
FDA 510(k) K202208 · Avery Dennison Belgie Bvba
510(k) numberK202208
Submission
- Device name
- BeneHold Surgical Incise Drape with CHG antimicrobial
- Applicant
- Avery Dennison Belgie Bvba
Turnhout, BE - Received
- August 6, 2020
- Decision date
- July 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Other 510(k)s with product code KKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
| K140250 | 3M Steri-Drape CHG Antimicrobial Incise DrapeKKX · Traditional | 3M Healthcare | 07/25/2014SE |
More from 3M Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K170407 | BD ChloraShield IV Dressing with CHG AntimicrobialFRO · Traditional | 07/17/2017SE |
| K152923 | BD ChloraShield IV Dressing with CHG AntimicrobialFRO · Special | 11/05/2015SE |
| K133764 | Chlorashield IV Dressing with CHG AntimicrobialFRO · Special | 03/13/2014SE |
| K113836 | Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)FRO · Traditional | 09/24/2012SE |
Questions and answers
When was BeneHold Surgical Incise Drape with CHG antimicrobial cleared by the FDA?
BeneHold Surgical Incise Drape with CHG antimicrobial (K202208) received a 510(k) decision of Substantially Equivalent on July 30, 2021, 358 days after the submission was received.
What is the product code of K202208?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.