K053008 is an FDA 510(k) clearance for the E-Z-EM ENDOSCOPIC CO2 REGULATOR, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on December 27, 2005, 62 days after receiving the submission on October 26, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K053008 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2005 |
| Decision Date | December 27, 2005 |
| Days to Decision | 62 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCX — Insufflator, Automatic Carbon-dioxide For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |