K182681 is an FDA 510(k) clearance for the AC5 Topical Gel. This device is classified as a Dressing, Wound, Drug.
Submitted by Arch Therapeutics, Inc. (Framingham, US). The FDA issued a Cleared decision on December 14, 2018, 79 days after receiving the submission on September 26, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K182681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2018 |
| Decision Date | December 14, 2018 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |