Submission Details
| 510(k) Number | K201096 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
CO2mbiLED
Jun 2020
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K201096 is an FDA 510(k) clearance for the CO2mbiLED, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, 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 review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | FCX — Insufflator, Automatic Carbon-dioxide For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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