Remington Medical Disposable Fluoro/Equipment Cover Model RMI8
FDA 510(k) K946060 · Remington Medical, Inc.
510(k) numberK946060
Submission
- Device name
- Remington Medical Disposable Fluoro/Equipment Cover Model RMI8
- Applicant
- Remington Medical, Inc.
Atlanta, GA, US - Received
- December 2, 1994
- Decision date
- April 27, 1995
- 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 |
|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | 11/20/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | 08/30/2024SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | 01/27/2022SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | 10/07/2021SE |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC)KNW · Traditional | 07/12/2019SE |
| K150266 | Remington Medical Inc. Tuohy Epidural NeedlesBSP · Traditional | 06/04/2015SE |
| K130282 | Remington Medical Centrefire 22 Biopsy InstrumentKNW · Traditional | 05/13/2013SE |
| K050884 | Adapter CableDTA · Traditional | 05/19/2005SE |
| K040266 | Core Needle BiopsyKNW · Traditional | 07/09/2004SE |
| K990428 | Drainage BagEXF · Traditional | 08/12/1999SE |
Questions and answers
When was Remington Medical Disposable Fluoro/Equipment Cover Model RMI8 cleared by the FDA?
Remington Medical Disposable Fluoro/Equipment Cover Model RMI8 (K946060) received a 510(k) decision of Substantially Equivalent on April 27, 1995, 146 days after the submission was received.
What is the product code of K946060?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.