K061316 is an FDA 510(k) clearance for the MEDLINE SURGICAL SPONGE SCANNER. This device is classified as a Counter, Sponge, Surgical (Class I - General Controls, product code LWH).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 2, 2006, 175 days after receiving the submission on May 11, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K061316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2006 |
| Decision Date | November 02, 2006 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LWH — Counter, Sponge, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2740 |