Endoscopic Videosystem
FDA 510(k) K822959 · Eder Instrument Co, Inc.
510(k) numberK822959
Submission
- Device name
- Endoscopic Videosystem
- Applicant
- Eder Instrument Co, Inc.
Milwaukee, Wi 53202, US - Received
- October 5, 1982
- Decision date
- October 22, 1982
- 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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| 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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| K802479 | Surgical Knives & ProbesHXB · Traditional | 10/31/1980SE |
| K792100 | Grasping Forcep (W/Four Prongs)GEN · Traditional | 11/13/1979SE |
| K791052 | Endoscopic InstrumentHET · Traditional | 08/03/1979SE |
Questions and answers
When was Endoscopic Videosystem cleared by the FDA?
Endoscopic Videosystem (K822959) received a 510(k) decision of Substantially Equivalent on October 22, 1982, 17 days after the submission was received.
What is the product code of K822959?
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.