FDA product code QGY: Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
QGY is the FDA product code for mobile / tablet software application to control settings of surgical and endoscopic camera. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under QGY. The average 510(k) review took 95 days (median 95).
Definition
Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.
Classification
| Field | Value |
|---|---|
| Device name | Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QGY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 95 |
Compare with all 510(k) review times · Search every QGY clearance
Top QGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew | 1 | 2019-05-21 |
Most recent QGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190367 | Smith & Nephew | Smith & Nephew Tablet Application | 2019-05-21 | 95 |
Recalls for QGY devices
openFDA lists no recalls for product code QGY.
Frequently asked questions
What is FDA product code QGY?
QGY is the FDA product code for mobile / tablet software application to control settings of surgical and endoscopic camera. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is QGY?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGY?
Across 1 cleared submissions the average was 95 days from receipt to decision (median 95).
Which companies have the most QGY clearances?
Smith & Nephew (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGY
- Run a recall and safety report across every QGY manufacturer
- Watch product code QGY 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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