K013219 is an FDA 510(k) clearance for the PROTOCO2L INSUFFLATOR MODEL 6400, 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 February 19, 2002, 146 days after receiving the submission on September 26, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K013219 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2001 |
| Decision Date | February 19, 2002 |
| Days to Decision | 146 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 |