K250204 is an FDA 510(k) clearance for the Endoscopic Camera System. This device is classified as a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II - Special Controls, product code FET).
Submitted by Shenzhen Sophway Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2025, 158 days after receiving the submission on January 24, 2025.
This device falls under the General & Plastic Surgery 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 | K250204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2025 |
| Decision Date | July 01, 2025 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |