K090879 is an FDA 510(k) clearance for the INSUFLOW CO2IONSHIELD. This device is classified as a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II - Special Controls, product code FCX).
Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on July 23, 2009, 114 days after receiving the submission on March 31, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K090879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2009 |
| Decision Date | July 23, 2009 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCX - Insufflator, Automatic Carbon-dioxide For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |