K100551 is an FDA 510(k) clearance for the ORLOCATE SYSTEM MODEL ORL 100, a Counter, Sponge, Surgical (Class I — General Controls, product code LWH), submitted by Haldor Advanced Technologies, Ltd. (Pardes Hanna, IL). The FDA issued a Cleared decision on August 12, 2010, 167 days after receiving the submission on February 26, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K100551 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 2010 |
| Decision Date | August 12, 2010 |
| Days to Decision | 167 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 |