Surgical Drapes
FDA 510(k) K011422 · Advance Medical Designs, Inc.
510(k) numberK011422
Submission
- Device name
- Surgical Drapes
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- May 9, 2001
- Decision date
- July 10, 2001
- 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 |
|---|---|---|
| K223689 | Disposable Needle Guides and GridsITX · Traditional | 08/02/2023SE |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound GelMUI · Traditional | 10/25/2017SE |
| K053495 | Equipment Slush DrapeKKX · Traditional | 03/16/2006SE |
| K011265 | Ultrasound Transducer CoverITX · Traditional | 10/30/2001SE |
| K012168 | Advance Medical Designs Fluid PouchKKX · Traditional | 09/18/2001SE |
| K003670 | Patient Drape, SurgicalKKX · Traditional | 01/26/2001SE |
| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | 07/05/1994SE |
| K911884 | Advance Pressure Monitor/High Pressure LinesDTL · Traditional | 07/05/1994SE |
| K915301 | Advance Stopcock/High Pressure StopcockDTL · Traditional | 12/11/1992SE |
| K911732 | Advance Disposable Control SyringeIZI · Traditional | 09/16/1991SE |
Questions and answers
When was Surgical Drapes cleared by the FDA?
Surgical Drapes (K011422) received a 510(k) decision of Substantially Equivalent on July 10, 2001, 62 days after the submission was received.
What is the product code of K011422?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.