KKX — Drape, Surgical Class II
FDA Device Classification
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
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 |