FDA product code GCO: Endoscope, Mirror
GCO is the FDA product code for endoscope, mirror. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under GCO, from 3 different applicants. The average 510(k) review took 67 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Mirror |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GCO clearance
Top GCO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytotech, Inc. | 1 | 1986-12-09 |
| Simpson/Basye, Inc. | 1 | 1986-07-30 |
| Johnson & Johnson Professionals, Inc. | 1 | 1979-04-12 |
Most recent GCO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862838 | Cytotech, Inc. | CYTOTECH HSV IGG ENZYME IMMUNOASSAY | 1986-12-09 | 137 |
| K862717 | Simpson/Basye, Inc. | HAND MIRROR (ENDOSCOPE) | 1986-07-30 | 13 |
| K790340 | Johnson & Johnson Professionals, Inc. | DELTA-ROL | 1979-04-12 | 50 |
Recalls for GCO devices
openFDA lists no recalls for product code GCO.
Frequently asked questions
What is FDA product code GCO?
GCO is the FDA product code for endoscope, mirror. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCO?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCO?
Across 3 cleared submissions the average was 67 days from receipt to decision (median 50).
Which companies have the most GCO clearances?
Cytotech, Inc. (1); Simpson/Basye, Inc. (1); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GCO
- Run a recall and safety report across every GCO manufacturer
- Watch product code GCO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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