Appendiceal Scope and Accessories, Flexible
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- Micro-Tech (Nanjing) Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
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.
What Is FDA Product Code SHU?
Appendiceal Scope And Accessories, Flexible is FDA product code SHU, Class 2, 21 CFR 876.1500.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 259 days from receipt to decision.