Equip Covers, Sterile
FDA 510(k) K897120 · Amedic USA
510(k) numberK897120
Submission
- Device name
- Equip Covers, Sterile
- Applicant
- Amedic USA
Sweden, SE - Received
- December 26, 1989
- Decision date
- January 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K892070 | General Ivt Needle Guide Kit, SterileHGL · Traditional | 09/05/1989SE |
| K892071 | General (Biopsy) Needle Guide Kit, SterileKNW · Traditional | 08/08/1989SE |
| K892069 | Extended Covers, SterileFFF · Traditional | 08/08/1989SE |
| K892068 | TRT (Acuson) Needle Guide Kit, SterileFCG · Traditional | 08/04/1989SE |
| K871467 | Biopsy Needle Guide Kit, SterileFCG · Traditional | 08/21/1987SE |
| K871609 | Ultrasound Transducer Sheaths, SterileITX · Traditional | 07/15/1987SE |
| K871565 | Ultrasound Transducer Gel, SterileJOT · Traditional | 07/15/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | 07/10/1987SE |
| K864219 | Transvaginal Ultrasound Biopsy Needle GuideHGL · Traditional | 03/27/1987SE |
Questions and answers
When was Equip Covers, Sterile cleared by the FDA?
Equip Covers, Sterile (K897120) received a 510(k) decision of Substantially Equivalent on January 4, 1990, 9 days after the submission was received.
What is the product code of K897120?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.