IntraMarX 3D Radiopaque Marker
FDA 510(k) K201106 · Anx Robotica Corp
510(k) numberK201106
Submission
- Device name
- IntraMarX 3D Radiopaque Marker
- Applicant
- Anx Robotica Corp
Pleasanton, CA, US - Received
- April 24, 2020
- Decision date
- May 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was IntraMarX 3D Radiopaque Marker cleared by the FDA?
IntraMarX 3D Radiopaque Marker (K201106) received a 510(k) decision of Substantially Equivalent on May 21, 2020, 27 days after the submission was received.
What is the product code of K201106?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.