SHU — Appendiceal Scope And Accessories, Flexible Class II

FDA Device Classification

Classification Details

Product Code
SHU
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252492micro-tech (nanjing) coVisualized Access and Delivery Catheter; PB Digital ControllerApril 24, 2026