Civco Probe Boot/Cord Cover
FDA 510(k) K943393 · CIVCO Medical Instruments Co., Inc.
510(k) numberK943393
Submission
- Device name
- Civco Probe Boot/Cord Cover
- Applicant
- CIVCO Medical Instruments Co., Inc.
Kalona, IA, US - Received
- July 14, 1994
- Decision date
- February 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K231783 | VitroPROITX · Special | 11/14/2023SE |
| K222052 | VitroPROITX · Traditional | 11/22/2022SE |
| K211270 | CIV-Clear coverITX · Traditional | 09/13/2021SE |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe…ITX · Traditional | 06/09/2017SE |
| K160806 | Verza Guidance SystemITX · Traditional | 08/05/2016SE |
| K131161 | EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…ITX · Traditional | 09/17/2013SE |
| K131528 | Non-Pyrogenic Ultrasound Transducer CoverITX · Traditional | 06/11/2013SE |
| K093713 | Ultrasound General Purpose Guidance SystemITX · Traditional | 01/19/2010SE |
| K080072 | MRI Patient Positioning DevicesIYE · Traditional | 06/04/2008SE |
| K013721 | Synthetic Polysioprene Ultrasound Transducer CoverITX · Traditional | 12/28/2001SE |
Questions and answers
When was Civco Probe Boot/Cord Cover cleared by the FDA?
Civco Probe Boot/Cord Cover (K943393) received a 510(k) decision of Substantially Equivalent on February 2, 1995, 203 days after the submission was received.
What is the product code of K943393?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.