Product code SHU— Gastroenterology, Urology
Visualized Access and Delivery Catheter; PB Digital Controller
- Classification name
- Appendiceal Scope And Accessories, Flexible
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SHU
FDA has cleared device under product code SHU, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SHU
Recent clearances under product code SHU
Data sourced from openFDA. This site is unofficial and independent of the FDA.