K201096 is an FDA 510(k) clearance for the CO2mbiLED. This device is classified as a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II - Special Controls, product code FCX).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on June 23, 2020, 60 days after receiving the submission on April 24, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K201096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2020 |
| Decision Date | June 23, 2020 |
| Days to Decision | 60 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 |