ControlRad Sterile Cover
FDA 510(k) K200238 · Controlrad, Inc.
510(k) numberK200238
Submission
- Device name
- ControlRad Sterile Cover
- Applicant
- Controlrad, Inc.
Norcross, GA, US - Received
- January 31, 2020
- Decision date
- April 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| 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 |
|---|---|---|
| K213455 | ControlRad Select Model ZOWB · Special | 11/24/2021SE |
| K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9OWB · Special | 07/01/2021SE |
| K202431 | ControlRad Select Model ZOWB · Traditional | 12/23/2020SE |
| K200663 | ControlRad Trace Model 9OWB · Traditional | 06/24/2020SE |
| K183109 | ControlRad Trace Model 8OWB · Traditional | 05/13/2019SE |
Questions and answers
When was ControlRad Sterile Cover cleared by the FDA?
ControlRad Sterile Cover (K200238) received a 510(k) decision of Substantially Equivalent on April 26, 2020, 86 days after the submission was received.
What is the product code of K200238?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.