K241532 is an FDA 510(k) clearance for the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100). This device is classified as a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II - Special Controls, product code FET).
Submitted by Shanghai SeeGen Photoelectric Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 22, 2024, 145 days after receiving the submission on May 30, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor..
| 510(k) Number | K241532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2024 |
| Decision Date | October 22, 2024 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FET - Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor. |