Endoscopic Camera System
FDA 510(k) K250204 · Shenzhen Sophway Technology Co., Ltd.
510(k) numberK250204
Submission
- Device name
- Endoscopic Camera System
- Applicant
- Shenzhen Sophway Technology Co., Ltd.
Shenzhen, CN - Received
- January 24, 2025
- Decision date
- July 1, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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|---|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | Olympus Medical Systems Corp. | 09/10/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | Fujifilm Corporation | 07/02/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | Olympus Medical Systems Corporation | 06/24/2026SE |
| K251734 | ProVee Video Processing Unit (PV-003)FET · Traditional | Proverum Limited | 09/24/2025SE |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K)FET · Traditional | Univlabs Technologies Private Limited | 08/11/2025SE |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET · Traditional | Fujifilm Corporation | 04/11/2025SE |
| K242067 | Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source…FET · Traditional | Olympus Corporations of the Americas | 04/02/2025SE |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F)FET · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 02/07/2025SE |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FET · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 10/22/2024SE |
| K241371 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)FET · Traditional | Olympus Medical Systems Corporation | 07/03/2024SE |
More from Olympus Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)GCJ · Traditional | 10/02/2025SE |
Questions and answers
When was Endoscopic Camera System cleared by the FDA?
Endoscopic Camera System (K250204) received a 510(k) decision of Substantially Equivalent on July 1, 2025, 158 days after the submission was received.
What is the product code of K250204?
The FDA product code is FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.