Compel Surgical Drapes
FDA 510(k) K923811 · Standard Textile Co., Inc.
510(k) numberK923811
Submission
- Device name
- Compel Surgical Drapes
- Applicant
- Standard Textile Co., Inc.
Cincinnati, OH, US - Received
- July 29, 1992
- Decision date
- February 23, 1993
- 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 |
| 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 |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K241214 | ProPel SG3 Surgical GownFYA · Traditional | 09/10/2024SE |
| K172207 | Standard Supreme Sterilization WrapperFRG · Traditional | 08/25/2017SE |
| K162162 | Barrier Supreme Sterilization WrapperFRG · Traditional | 11/04/2016SE |
| K060181 | COMPE1 1 -Ply Surgical GownsFYA · Traditional | 03/07/2006SE |
| K041653 | Compel 1-PLY Surgical Gowns; Compel Isolation GownsFYA · Traditional | 07/01/2005SE |
| K041540 | Combosafe (Europe) and Promax (US) Surgical GownsFYA · Traditional | 05/05/2005SE |
| K041539 | Compel Surgical GownsFYA · Traditional | 04/28/2005SE |
| K041541 | Compel MLR Surgical GownsFYA · Traditional | 03/16/2005SE |
| K012268 | TrimaxFYA · Traditional | 12/03/2001SE |
| K012807 | Modification to: Compel Surgical DrapesKKX · Special | 10/11/2001SE |
Questions and answers
When was Compel Surgical Drapes cleared by the FDA?
Compel Surgical Drapes (K923811) received a 510(k) decision of Substantially Equivalent on February 23, 1993, 209 days after the submission was received.
What is the product code of K923811?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.