Endoscope, Mirror
The Endoscope, Mirror (product code GCO) is an endoscope that uses a mirror-based optical system to redirect the field of view, allowing visualization of internal body structures at angles not achievable with standard forward-viewing instruments during gastroenterological or urological procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.
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Basic Information
- Product Code
- GCO
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K862838 | CYTOTECH HSV IGG ENZYME IMMUNOASSAY | Dec 09, 1986 | Substantially Equivalent | Cytotech, Inc. |
| K862717 | HAND MIRROR (ENDOSCOPE) | Jul 30, 1986 | Substantially Equivalent | Simpson/Basye, Inc. |
| K790340 | DELTA-ROL | Apr 12, 1979 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |