Sterile Abdominal Pad
FDA 510(k) K801068 · Medspec Corp.
510(k) numberK801068
Submission
- Device name
- Sterile Abdominal Pad
- Applicant
- Medspec Corp.
Mchenry, IL, US - Received
- May 6, 1980
- Decision date
- May 20, 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 |
|---|---|---|
| K813012 | Sterile Basin SetsLDQ · Traditional | 11/06/1981SE |
| K812711 | Sterile Gauze Pads 12PLYNAB · Traditional | 11/02/1981SE |
| K812710 | Sterile Laparotomy Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K812707 | Sterile Dissector Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K812709 | Sterile Dental RollEFN · Traditional | 10/23/1981SE |
| K810071 | Sterile Silicone TubingGBS · Traditional | 02/12/1981SE |
| K810069 | Sterile AirwayCAE · Traditional | 02/02/1981SE |
| K802060 | Sterile Tonsil SpongesGDY · Traditional | 10/10/1980SE |
| K801069 | Sterile Isolation GownFYC · Traditional | 05/20/1980SE |
| K800279 | Medspec Rubber Bands · Traditional | 05/02/1980SE |
Questions and answers
When was Sterile Abdominal Pad cleared by the FDA?
Sterile Abdominal Pad (K801068) received a 510(k) decision of Substantially Equivalent on May 20, 1980, 14 days after the submission was received.
What is the product code of K801068?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.