IntraMarX 3D Radiopaque Marker— 510(k) K201106
Substantially EquivalentAnx Robotica Corp
FDA 510(k) clearance K201106 for IntraMarX 3D Radiopaque Marker, Substantially Equivalent on 2020-05-21. Applicant: Anx Robotica Corp. Device class: 2.
Clearance details
- Applicant
- Anx Robotica Corp
- Product code
- Code FFX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code FFX
view allMore clearances from Anx Robotica Corp
view all- K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
- K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System
- K221608 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
- K203192 — NaviCam Xpress Stomach System
- K191087 — IntraMarX Radiopaque Markers
Adverse events under product code FFX
product code FFX- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.