Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor
FDA 510(k) K994199 · Custom Medical Products, Inc.
510(k) numberK994199
Submission
- Device name
- Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor
- Applicant
- Custom Medical Products, Inc.
Asheville, NC, US - Received
- December 13, 1999
- Decision date
- June 9, 2000
- 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 |
|---|---|---|
| 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 |
| K931418 | Surgical DrapeKKX · 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 Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor cleared by the FDA?
Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor (K994199) received a 510(k) decision of Substantially Equivalent on June 9, 2000, 179 days after the submission was received.
What is the product code of K994199?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.