Sterile Dispos Surgical Drape/C-Section Drape
FDA 510(k) K905465 · Angiosystems, Inc.
510(k) numberK905465
Submission
- Device name
- Sterile Dispos Surgical Drape/C-Section Drape
- Applicant
- Angiosystems, Inc.
Great Neck, NY, US - Received
- December 5, 1990
- Decision date
- February 11, 1991
- 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 |
|---|---|---|
| K905464 | Medical Procedure Kits/Arterial Blood SamplingCBT · Traditional | 05/31/1991SEKD |
| K905459 | Surgical Procedure Tray/Laparoscopy CholecystectomLRO · Traditional | 04/05/1991SE |
| K905461 | Procedure Kit/Routine Dental ProceduresEKS · Traditional | 03/05/1991SEKD |
| K905466 | Sterile Disposable Surgical Drape/Abdominal DrapeKKX · Traditional | 02/11/1991SE |
| K905462 | Procedure Tray/For Various Ophthalmic ProceduresLRP · Traditional | 02/06/1991SE |
| K905460 | Sterile Disposable Drape/Ophthalmic SurgeryHMT · Traditional | 02/06/1991SE |
| K905463 | General Medical Procedure Kit/Skin PreparationFOZ · Traditional | 01/22/1991SEKD |
| K864688 | Arnold-King Pressure DressingNAD · Traditional | 01/12/1987SE |
| K843260 | Angiosys Femoral Angiography DrapeKKX · Traditional | 09/21/1984SE |
| K843259 | Angio Sys Fluoroscope Drape · Traditional | 09/21/1984SE |
Questions and answers
When was Sterile Dispos Surgical Drape/C-Section Drape cleared by the FDA?
Sterile Dispos Surgical Drape/C-Section Drape (K905465) received a 510(k) decision of Substantially Equivalent on February 11, 1991, 68 days after the submission was received.
What is the product code of K905465?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.