SHU

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Appendiceal Scope And Accessories, Flexible

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

FDA 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.

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