Endoscopic Video Imaging System/Component, Gastroenterology-Urology
The Endoscopic Video Imaging System/Component for Gastroenterology-Urology (product code OCS) is a gastroenterology and urology device that projects images from an endoscope to a monitor, allowing for visualization of body cavities including the GI and GU tracts during diagnostic and therapeutic procedures. It encompasses the camera, processor, and display components of an endoscopic imaging system. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCS
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100852 | STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 | May 06, 2010 | Substantially Equivalent | Stryker Communications |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.