Medilase 5010 Endoscope Console
FDA 510(k) K900380 · Medical Laser, Inc.
510(k) numberK900380
Submission
- Device name
- Medilase 5010 Endoscope Console
- Applicant
- Medical Laser, Inc.
Minneapolis, MN, US - Received
- January 26, 1990
- Decision date
- May 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FET · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 10/22/2024SE |
More from Shanghai SeeGen Photoelectric Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K913136 | Laser Endoscope Disc Decompression KitsLRO · Traditional | 11/01/1991SESK |
| K912265 | Medilase Semi-Rigid Instrod Sheath Series AE1000FED · Traditional | 10/10/1991SE |
| K912447 | Series 5000 Endoscope Console Models 5100 and 5200FET · Traditional | 09/27/1991SE |
| K912089 | Modified Series 2100 EndoscopesODF · Traditional | 08/12/1991SE |
| K901464 | Medilase Series 2200 EndoscopeGCM · Traditional | 08/07/1990SE |
| K900894 | Medilase Series 2100 EndoscopeGCQ · Traditional | 06/22/1990SE |
| K895837 | Medilase System 2010L Laser LithotriptorGEX · Traditional | 12/14/1989SE |
Questions and answers
When was Medilase 5010 Endoscope Console cleared by the FDA?
Medilase 5010 Endoscope Console (K900380) received a 510(k) decision of Substantially Equivalent on May 15, 1990, 109 days after the submission was received.
What is the product code of K900380?
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.