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— 510(k) K221608
Substantially EquivalentAnx Robotica Corp
FDA 510(k) clearance K221608 for 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, Substantially Equivalent on 2022-11-22. Applicant: Anx Robotica Corp. Device class: 2.
Clearance details
- Applicant
- Anx Robotica Corp
- Product code
- Code QKZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1310
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Recent devices under product code QKZ
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)
- K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
- K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System
- K203192 — NaviCam Xpress Stomach System
- DEN190037 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
More clearances from Anx Robotica Corp
view allData sourced from openFDA. This site is unofficial and independent of the FDA.