Surgical Drapes and Accessories Using Pcce Film
FDA 510(k) K870123 · Avery Intl.
510(k) numberK870123
Submission
- Device name
- Surgical Drapes and Accessories Using Pcce Film
- Applicant
- Avery Intl.
Mentor, OH, US - Received
- January 12, 1987
- Decision date
- February 4, 1987
- 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 |
|---|---|---|
| K870093 | Medical Adhesive Tape & Bandage Using Pcce FilmKGX · Traditional | 02/05/1987SN |
| K870092 | Medical Adhesive Tape & Bandage Using Hytrel FilmKGX · Traditional | 02/05/1987SN |
| K870021 | Medical Adhesive Tape and Adhesive BandageKGX · Traditional | 02/05/1987SN |
| K870124 | Surgical Drapes and Accessories Using Pebax FilmKKX · Traditional | 02/04/1987SE |
| K870122 | Surgical Drapes and Accessories Using Hytrel FilmKKX · Traditional | 02/04/1987SE |
| K870091 | IV Securement Device Using Pcce Thermo. FilmKGX · Traditional | 02/04/1987SE |
| K870090 | IV Securement Device Using Hytrel Thermo. FilmKGX · Traditional | 02/04/1987SE |
| K870020 | IV Securement DeviceKGX · Traditional | 02/04/1987SE |
| K862438 | Surgical Drapes and Drape AccessoriesKKX · Traditional | 07/16/1986SN |
| K854464 | IV Securement DevicesFRO · Traditional | 03/03/1986SN |
Questions and answers
When was Surgical Drapes and Accessories Using Pcce Film cleared by the FDA?
Surgical Drapes and Accessories Using Pcce Film (K870123) received a 510(k) decision of Substantially Equivalent on February 4, 1987, 23 days after the submission was received.
What is the product code of K870123?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.