K223741 is an FDA 510(k) clearance for the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R. This device is classified as a Choledochoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FBN).
Submitted by Zhuhai Pusen Medical Technology Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on June 22, 2023, 190 days after receiving the submission on December 14, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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)..
| 510(k) Number | K223741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2022 |
| Decision Date | June 22, 2023 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| 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). |