K180711 is an FDA 510(k) clearance for the FUJIFILM Endoscopic CO2 Regulator GW-100. This device is classified as a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II - Special Controls, product code FCX).
Submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on May 25, 2018, 67 days after receiving the submission on March 19, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K180711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2018 |
| Decision Date | May 25, 2018 |
| Days to Decision | 67 days |
| Submission Type | Special |
| 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 |