K101887 is an FDA 510(k) clearance for the CONFIDENT SURGERY SUITE 300, MODEL CSS300. This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Surgiceye GmbH (Munich, Bavaria, DE). The FDA issued a Cleared decision on March 22, 2011, 259 days after receiving the submission on July 6, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K101887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2010 |
| Decision Date | March 22, 2011 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |