FDA product code OCS: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
OCS is the FDA product code for endoscopic video imaging system/component, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under OCS. The average 510(k) review took 41 days (median 41). FDA has posted 1 recall for OCS devices.
Definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| 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 OCS clearance
Top OCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Communications | 1 | 2010-05-06 |
Most recent OCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100852 | Stryker Communications | STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 | 2010-05-06 | 41 |
Recalls for OCS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code OCS?
OCS is the FDA product code for endoscopic video imaging system/component, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCS?
Across 1 cleared submissions the average was 41 days from receipt to decision (median 41).
Which companies have the most OCS clearances?
Stryker Communications (1).
Have OCS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-01-17.
Next steps
- Run an FDA pathway report with predicate devices for product code OCS
- Run a recall and safety report across every OCS manufacturer
- Watch product code OCS 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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