K162332 is an FDA 510(k) clearance for the Nexcore GI Insufflator, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by Nexcore Technology, LLC (Winchester, US). The FDA issued a Cleared decision on September 29, 2016, 41 days after receiving the submission on August 19, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K162332 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 2016 |
| Decision Date | September 29, 2016 |
| Days to Decision | 41 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 |