MediClear PreOp
FDA 510(k) K163556 · Covalontechnologies, Inc.
510(k) numberK163556
Submission
- Device name
- MediClear PreOp
- Applicant
- Covalontechnologies, Inc.
Mississsauga, CA - Received
- December 19, 2016
- Decision date
- September 14, 2017
- 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 |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| 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 |
|---|---|---|
| K150550 | SilverCoat Silicone Foley CatheterEZL · Traditional | 11/24/2015SE |
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverFRO · Traditional | 08/13/2012SE |
| K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverFRO · Traditional | 05/04/2012SE |
| K043296 | Colactive AG Collagen with Silver Antimicrobial DressingFRO · Traditional | 06/06/2005SE |
| K050177 | Colactive Collagen Wound DressingKGN · Traditional | 04/27/2005SE |
Questions and answers
When was MediClear PreOp cleared by the FDA?
MediClear PreOp (K163556) received a 510(k) decision of Substantially Equivalent on September 14, 2017, 269 days after the submission was received.
What is the product code of K163556?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.