Submission Details
| 510(k) Number | K071355 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 2007 |
| Decision Date | May 24, 2007 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
SMARTSPONGE SYSTEM
May 2007
Decision
9d
Days
Class 1
Risk
About This 510(k) Submission
K071355 is an FDA 510(k) clearance for the SMARTSPONGE 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 May 24, 2007, 9 days after receiving the submission on May 15, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.
Device Classification
| Product Code | LWH — Counter, Sponge, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.2740 |
Manufacturer
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