Imc Surgical Drape
FDA 510(k) K100208 · International Medsurg Connection
510(k) numberK100208
Submission
- Device name
- Imc Surgical Drape
- Applicant
- International Medsurg Connection
Schaumburg, IL, US - Received
- January 25, 2010
- Decision date
- April 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K110882 | Imc Insulin SyringeFMF · Traditional | 08/18/2011SE |
| K110656 | Imc Blood Collection NeedleFMI · Traditional | 08/18/2011SE |
| K102584 | Imc Hypodermic NeedleFMI · Traditional | 01/14/2011SE |
| K102969 | Imc Piston SyringesFMF · Special | 12/20/2010SE |
| K100991 | Imc Surgical DrapeKKX · Traditional | 10/05/2010SE |
| K100846 | Imc Surgical Face MaskFXX · Traditional | 08/16/2010SE |
| K052169 | Imc Surgical DrapesKKX · Traditional | 11/17/2005SE |
| K042893 | Under Buttocks DrapeKKX · Traditional | 03/11/2005SE |
| K023808 | Irrigation SetsLJH · Traditional | 03/10/2003SE |
| K022159 | Piston Syringe & Hypodermic NeedleFMF · Traditional | 11/07/2002SE |
Questions and answers
When was Imc Surgical Drape cleared by the FDA?
Imc Surgical Drape (K100208) received a 510(k) decision of Substantially Equivalent on April 20, 2010, 85 days after the submission was received.
What is the product code of K100208?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.