Surgical Drape
FDA 510(k) K931418 · Custom Medical Products, Ltd.
510(k) numberK931418
Submission
- Device name
- Surgical Drape
- Applicant
- Custom Medical Products, Ltd.
Asheville, NC, US - Received
- March 22, 1993
- Decision date
- May 5, 1994
- 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 |
| 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 |
|---|---|---|
| K994199 | Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure…KKX · Traditional | 06/09/2000SE |
| K931417 | Sterile Equipment CoversMMP · Traditional | 07/06/1995SE |
| K931456 | Surgical Drape and Gown TrayFYA · Traditional | 07/08/1994SE |
| K931455 | Head SheetKKX · Traditional | 05/05/1994SE |
| K930815 | Abdominal / Thoracic Patient DrapeKKX · Traditional | 05/05/1994SE |
| K931844 | Custom Procedure Medical Tray or KitLRO · Traditional | 01/25/1994SEKD |
| K926519 | Surgical GownFYA · Traditional | 08/12/1993SE |
| K900848 | Enema Kit 'Straight' DesignFCE · Traditional | 04/13/1990SE |
| K900847 | Enema Kit 'Y' DesignFCE · Traditional | 04/13/1990SE |
| K895084 | ApertureIZS · Traditional | 10/27/1989SE |
Questions and answers
When was Surgical Drape cleared by the FDA?
Surgical Drape (K931418) received a 510(k) decision of Substantially Equivalent on May 5, 1994, 409 days after the submission was received.
What is the product code of K931418?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.