Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA
FDA 510(k) K242067 · Olympus Corporations of the Americas
510(k) numberK242067
Submission
- Device name
- Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA
- Applicant
- Olympus Corporations of the Americas
Westborough, MA, US - Received
- July 15, 2024
- Decision date
- April 2, 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.
Other 510(k)s with product code FET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
Questions and answers
When was Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA cleared by the FDA?
Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA (K242067) received a 510(k) decision of Substantially Equivalent on April 2, 2025, 261 days after the submission was received.
What is the product code of K242067?
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.