White Knight Bovie Cord/Suction Tube
FDA 510(k) K802213 · G.D. Searle and Co.
510(k) numberK802213
Submission
- Device name
- White Knight Bovie Cord/Suction Tube
- Applicant
- G.D. Searle and Co.
Mchenry, IL, US - Received
- September 12, 1980
- Decision date
- October 10, 1980
- 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 |
|---|---|---|
| K821159 | In-Line Oxygen Monitoring SystemDRY · Traditional | 05/25/1982SE |
| K811068 | Bypass CoilKPY · Traditional | 05/27/1981SE |
| K811071 | Venous Oxygen ProbeCCE · Traditional | 05/05/1981SE |
| K803238 | Intravascular CatheterFOZ · Traditional | 04/23/1981SE |
| K810630 | Silicone Elastomer Coated Latex FoleyKOD · Traditional | 03/31/1981SE |
| K810131 | Administration SetFPD · Traditional | 02/26/1981SE |
| K802485 | Searle Vascular LoopsKDC · Traditional | 02/12/1981SE |
| K801805 | Metronidazole DiscsJWY · Traditional | 02/10/1981SE |
| K810112 | SWR Disposable Prep RazorKDC · Traditional | 02/04/1981SE |
| K802280 | White Knight Drape SealKKX · Traditional | 10/10/1980SE |
Questions and answers
When was White Knight Bovie Cord/Suction Tube cleared by the FDA?
White Knight Bovie Cord/Suction Tube (K802213) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 28 days after the submission was received.
What is the product code of K802213?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.