K073180 is an FDA 510(k) clearance for the SMARTSPONGE PLUS SYSTEM, a Counter, Sponge, Surgical (Class I — General Controls, product code LWH), submitted by Clearcount Medical Solutions, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 19, 2007, 6 days after receiving the submission on November 13, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K073180 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2007 |
| Decision Date | November 19, 2007 |
| Days to Decision | 6 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 |