Disp. Fenestrated Surg. Drape Sheets
FDA 510(k) K802359 · American Convertors Div., American Pharmaseal
510(k) numberK802359
Submission
- Device name
- Disp. Fenestrated Surg. Drape Sheets
- Applicant
- American Convertors Div., American Pharmaseal
Mchenry, IL, US - Received
- September 26, 1980
- Decision date
- October 31, 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 |
|---|---|---|
| K840957 | Antimicrobial Incise DrapeKKX · Traditional | 06/07/1984SE |
| K832137 | Convertors Flash Sterilizing TrayFSM · Traditional | 08/12/1983SE |
| K830786 | Disimetric Release of Instranetics RadKOA · Traditional | 05/18/1983SE |
| K820994 | Absorb Furn SheetFPY · Traditional | 05/13/1982SE |
| K813419 | Comfort Cushion Dry Burn Pad IIINAB · Traditional | 01/22/1982SE |
| K813296 | Convertors Sterile Disp. Lap Sponge IIEFQ · Traditional | 12/29/1981SE |
| K813078 | Contura Dispos. Surg. Face MaskFXX · Traditional | 12/18/1981SE |
| K812554 | Tomac Sterile Disp. Lap SpongeGDY · Traditional | 09/24/1981SE |
| K802919 | Iso-Bac Instrument WrapFRG · Traditional | 02/02/1981SE |
| K802998 | Patient Care Disposable Infant ShirtsKME · Traditional | 12/22/1980SE |
Questions and answers
When was Disp. Fenestrated Surg. Drape Sheets cleared by the FDA?
Disp. Fenestrated Surg. Drape Sheets (K802359) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 35 days after the submission was received.
What is the product code of K802359?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.