NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether— 510(k) K233229
Substantially EquivalentAnx Robotica Corporation
FDA 510(k) clearance K233229 for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether, Substantially Equivalent on 2024-01-05. Applicant: Anx Robotica Corporation. Device class: 2.
Clearance details
- Applicant
- Anx Robotica Corporation
- Product code
- Code NEZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Recent devices under product code NEZ
view allMore clearances from Anx Robotica Corporation
view allAdverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
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.