Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
FDA 510(k) K241532 · Shanghai SeeGen Photoelectric Technology Co., Ltd.
510(k) numberK241532
Submission
- Device name
- Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
- Applicant
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
Shanghai, CN - Received
- May 30, 2024
- Decision date
- October 22, 2024
- 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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|---|---|---|---|
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| 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 |
| K250204 | Endoscopic Camera SystemFET · Traditional | Shenzhen Sophway Technology Co., Ltd. | 07/01/2025SE |
| 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 |
| 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 |
|---|---|---|
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | 01/30/2026SE |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)FBN · Special | 03/07/2025SE |
| K222499 | Disposable Endoscope Valves KitODC · Traditional | 11/22/2023SE |
| K222261 | Flexible Video-Choledochoscope SystemFBN · Traditional | 04/20/2023SE |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope SystemFGB · Traditional | 02/22/2022SE |
Questions and answers
When was Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) cleared by the FDA?
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (K241532) received a 510(k) decision of Substantially Equivalent on October 22, 2024, 145 days after the submission was received.
What is the product code of K241532?
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.