Submission Details
| 510(k) Number | K231861 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 2023 |
| Decision Date | July 21, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
EndoflipTM 300 System
Jul 2023
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K231861 is an FDA 510(k) clearance for the EndoflipTM 300 System, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Covidien, LLC (Santa Clara, US). The FDA issued a Cleared decision on July 21, 2023, 28 days after receiving the submission on June 23, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
Device Classification
| Product Code | FFX — System, Gastrointestinal Motility (electrical) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1725 |
Manufacturer
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