Surgical Gown/Scrub/Laparotomy/Mayo Stand/Back Tab
FDA 510(k) K883424 · Intera Corp.
510(k) numberK883424
Submission
- Device name
- Surgical Gown/Scrub/Laparotomy/Mayo Stand/Back Tab
- Applicant
- Intera Corp.
Chattanooga, TN, US - Received
- August 15, 1988
- Decision date
- September 6, 1988
- 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 |
|---|---|---|
| K891686 | Lib System, Baby/Adult DiaperEYQ · Traditional | 05/31/1989SE |
| K885185 | Intera Shield and Intera UndergarmentEYQ · Traditional | 02/08/1989SE |
| K883787 | Reusable Adult Incontinent DiaperEYQ · Traditional | 11/07/1988SE |
| K863732 | Surgical Drape & Drape AccessoriesKKX · Traditional | 10/23/1986SE |
| K862380 | Mattress CoverEYQ · Traditional | 07/28/1986SE |
Questions and answers
When was Surgical Gown/Scrub/Laparotomy/Mayo Stand/Back Tab cleared by the FDA?
Surgical Gown/Scrub/Laparotomy/Mayo Stand/Back Tab (K883424) received a 510(k) decision of Substantially Equivalent on September 6, 1988, 22 days after the submission was received.
What is the product code of K883424?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.