FDA product code SHU: Appendiceal Scope And Accessories, Flexible
SHU is the FDA product code for appendiceal scope and accessories, flexible. 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 SHU, 1 in the last five years. The average 510(k) review took 259 days (median 259); 259 days on average over the last three years.
Definition
Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall.
Classification
| Field | Value |
|---|---|
| Device name | Appendiceal Scope And Accessories, Flexible |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for SHU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 259 |
Compare with all 510(k) review times · Search every SHU clearance
Top SHU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | 1 | 2026-04-24 |
Most recent SHU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252492 | Micro-Tech (Nanjing) Co., Ltd. | Visualized Access and Delivery Catheter; PB Digital Controller | 2026-04-24 | 259 |
Recalls for SHU devices
openFDA lists no recalls for product code SHU.
Frequently asked questions
What is FDA product code SHU?
SHU is the FDA product code for appendiceal scope and accessories, flexible. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is SHU?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code SHU?
Across 1 cleared submissions the average was 259 days from receipt to decision (median 259).
Which companies have the most SHU clearances?
Micro-Tech (Nanjing) Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHU
- Run a recall and safety report across every SHU manufacturer
- Watch product code SHU 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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