SHU · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
Classification
FDA Product Code
SHU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.1500
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.