Patient Drape, Surgical
FDA 510(k) K003670 · Advance Medical Designs, Inc.
510(k) numberK003670
Submission
- Device name
- Patient Drape, Surgical
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- November 28, 2000
- Decision date
- January 26, 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 |
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| 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 |
| K011422 | Surgical DrapesKKX · Traditional | 07/10/2001SE |
| 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 Patient Drape, Surgical cleared by the FDA?
Patient Drape, Surgical (K003670) received a 510(k) decision of Substantially Equivalent on January 26, 2001, 59 days after the submission was received.
What is the product code of K003670?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.