K242666 is an FDA 510(k) clearance for the Fecobionics Anorectal System, a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II — Special Controls, product code KLA), submitted by Gi Bionics, LLC (San Diego, US). The FDA issued a Cleared decision on February 12, 2025, 160 days after receiving the submission on September 5, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K242666 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2024 |
| Decision Date | February 12, 2025 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1725 |