K230645 is an FDA 510(k) clearance for the BeneHold™ Surgical Incise Drape with CHG antimicrobial II. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Avery Dennison Medical , Ltd. (Longford, IE). The FDA issued a Cleared decision on October 25, 2023, 231 days after receiving the submission on March 8, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K230645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2023 |
| Decision Date | October 25, 2023 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX - Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |