K202208 is an FDA 510(k) clearance for the BeneHold Surgical Incise Drape with CHG antimicrobial. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on July 30, 2021, 358 days after receiving the submission on August 6, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K202208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2020 |
| Decision Date | July 30, 2021 |
| Days to Decision | 358 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 |