Endoscopic Video System and Endoscopic Video Camera
FDA 510(k) K934623 · Endomedix
510(k) numberK934623
Submission
- Device name
- Endoscopic Video System and Endoscopic Video Camera
- Applicant
- Endomedix
Irvine, CA, US - Received
- September 27, 1993
- Decision date
- December 2, 1993
- 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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| 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 |
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| 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 |
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| K922082 | Laparoscopic IntroducerGCJ · Traditional | 08/03/1992SE |
Questions and answers
When was Endoscopic Video System and Endoscopic Video Camera cleared by the FDA?
Endoscopic Video System and Endoscopic Video Camera (K934623) received a 510(k) decision of Substantially Equivalent on December 2, 1993, 66 days after the submission was received.
What is the product code of K934623?
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.