K093557 is an FDA 510(k) clearance for the SMARTWAND-DTX, a Counter, Sponge, Surgical (Class I — General Controls, product code LWH), submitted by Clearcount Medical Solutions (Pittsburgh, US). The FDA issued a Cleared decision on December 18, 2009, 32 days after receiving the submission on November 16, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K093557 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 2009 |
| Decision Date | December 18, 2009 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LWH — Counter, Sponge, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.2740 |