S-357 Video Imaging System
FDA 510(k)Class II (US FDA 510(k))
by Sopro
Identifiers
- 510(k) Number
- K972540 FDA 510(k)
- FDA Product Code
- FET FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The S-357 Video Imaging System is an endoscopic video imaging system designed for capturing and processing optical images from internal body cavities, hollow organs, and canals. It functions as a component of endoscopic procedures, converting visual inputs into video signals for real-time visualization and recording during surgical interventions.
This device is intended for use in clinical or surgical settings by medical professionals, providing a video feed for display on monitors. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance. The system is reusable and intended for use in environments such as operating rooms, with no specific sterility or MRI safety restrictions mentioned in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: S-357 VIDEO IMAGING SYSTEM (K973798) — FDA 510(k) | Innolitics, S-357 VIDEO IMAGING SYSTEM (K972540) — FDA 510(k) | Innolitics, PDF K972540 - S-357 Video Imaging System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972540 | Class II | Active |
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Manufacturer
- Manufacturer
- Sopro
Sources (1)
- FDA 510(k) K972540 24 fields · synced Sep 19, 2026