FDA product code SGH: Ultrasound Imaging For Vascular Access For Hemodialysis
SGH is the FDA product code for ultrasound imaging for vascular access for hemodialysis. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under SGH, 1 in the last five years. The average 510(k) review took 140 days (median 140); 140 days on average over the last three years.
Definition
Ultrasound imaging for vascular access for hemodialysis
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound Imaging For Vascular Access For Hemodialysis |
| Device class | Class II |
| Regulation | 21 CFR 892.1560 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for SGH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 140 |
Compare with all 510(k) review times · Search every SGH clearance
Top SGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| X9, Inc. | 1 | 2025-10-17 |
Most recent SGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251673 | X9, Inc. | X9 Ultrasound System | 2025-10-17 | 140 |
Recalls for SGH devices
openFDA lists no recalls for product code SGH.
Frequently asked questions
What is FDA product code SGH?
SGH is the FDA product code for ultrasound imaging for vascular access for hemodialysis. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Gastroenterology and Urology panel.
What device class is SGH?
Class II, regulation 21 CFR 892.1560. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGH?
Across 1 cleared submissions the average was 140 days from receipt to decision (median 140).
Which companies have the most SGH clearances?
X9, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGH
- Run a recall and safety report across every SGH manufacturer
- Watch product code SGH 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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