K063786 is an FDA 510(k) clearance for the ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2. This device is classified as a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II - Special Controls, product code FCX).
Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on March 5, 2007, 74 days after receiving the submission on December 21, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K063786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2006 |
| Decision Date | March 05, 2007 |
| Days to Decision | 74 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 |