KKX — Drape, Surgical, Antimicrobial Class II
FDA product code KKX covers "Drape, Surgical, Antimicrobial", a Class II medical device regulated under 21 CFR 878.4370. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KKX
- Device Class
- Class II
- Regulation Number
- 878.4370
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230645 | avery dennison medical | BeneHold Surgical Incise Drape with CHG antimicrobial II | October 25, 2023 |
| K222578 | 3m | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | May 18, 2023 |
| K202208 | avery dennison belgie bvba | BeneHold Surgical Incise Drape with CHG antimicrobial | July 30, 2021 |
| K200238 | controlrad | ControlRad Sterile Cover | April 26, 2020 |
| K163556 | covalontechnologies | MediClear PreOp | September 14, 2017 |
| K133080 | foshan nanhai plus medical co | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | June 24, 2015 |
| K141324 | weihai hongyu nonwoven fabric products co | HONGYU DISPOSABLE SURGICAL DRAPES | April 14, 2015 |
| K140195 | griffith-lucas | SURGICAL DRAPE | September 10, 2014 |
| K140330 | 3m healthcare | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | August 18, 2014 |
| K141438 | whitney medical solutions | WHITNEY MEDICAL SOLUTIONS ESHIELD | August 14, 2014 |
| K140250 | 3m healthcare | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | July 25, 2014 |
| K140064 | covidien | SURGISLEEVE WOUND PROTECTOR | March 12, 2014 |
| K131571 | advanced vascular dynamics | AVD RIGHT RADIAL DRAPE | January 31, 2014 |
| K130404 | cardinal health200 | TIBURON SURGICAL DRAPE | July 5, 2013 |
| K121436 | das medical | DAS MEDICAL EQUIPMENT DRAPES | June 6, 2013 |
| K121919 | exact medical manufacturing | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | February 14, 2013 |
| K122000 | changzhou holymed products co | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | December 12, 2012 |
| K112378 | cobes industries co | COBES SURGICAL DRAPE | May 8, 2012 |
| K111458 | gri medical and electronic technology co | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS | December 1, 2011 |
| K112136 | kunshan jiehong nonwoven product co | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | September 29, 2011 |