Citation Medical Scope Procedure Pack
FDA 510(k) K912490 · Citation Medical Corp.
510(k) numberK912490
Submission
- Device name
- Citation Medical Scope Procedure Pack
- Applicant
- Citation Medical Corp.
Reno, NV, US - Received
- June 4, 1991
- Decision date
- August 16, 1991
- 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 |
|---|---|---|
| K951941 | Citation Multiple Use Delta ScopeHRX · Traditional | 07/14/1995SE |
| K945390 | Citation Delta ScopeHRX · Traditional | 06/23/1995SE |
| K946290 | Citation Power ToolHRX · Traditional | 06/15/1995SE |
| K951249 | Citation SinuscopeEOB · Traditional | 04/10/1995SE |
| K944976 | Bronchoscope,Non-RigidEOQ · Traditional | 12/21/1994SE |
| K940847 | Endoscopic Plantar Fascia KitHRX · Traditional | 10/11/1994SE |
| K941563 | The Biopsy ToolFCG · Traditional | 09/26/1994SE |
| K924494 | Citscope, Bendable -- ModificationHRX · Traditional | 05/26/1993SN |
| K922144 | Citscope (Model Extensions)HRX · Traditional | 08/05/1992SE |
| K921692 | Integrated Video SystemHRX · Traditional | 07/01/1992SE |
Questions and answers
When was Citation Medical Scope Procedure Pack cleared by the FDA?
Citation Medical Scope Procedure Pack (K912490) received a 510(k) decision of Substantially Equivalent on August 16, 1991, 73 days after the submission was received.
What is the product code of K912490?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.