K243535 is an FDA 510(k) clearance for the Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U), a Choledochoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FBN), submitted by Shanghai SeeGen Photoelectric Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 7, 2025, 112 days after receiving the submission on November 15, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K243535 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 2024 |
| Decision Date | March 07, 2025 |
| Days to Decision | 112 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBN — Choledochoscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Bile Ducts. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |