Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MotiliCap GI Monitoring System

K-Number: K250493 · 2025-05-21

ApplicantAnx Robotica Corporation
Decision Date2025-05-21
Product CodeNYV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MotiliCap GI Monitoring System is a medical device manufactured by Anx Robotica Corporation. It received FDA 510(k) clearance on 2025-05-21 under approval number K250493. The device is classified under product code NYV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MotiliCap GI Monitoring System?

MotiliCap GI Monitoring System is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Anx Robotica Corporation. The 510(k) number is K250493.

When was MotiliCap GI Monitoring System approved by the FDA?

MotiliCap GI Monitoring System received FDA 510(k) clearance on 2025-05-21, under approval number K250493.

What company makes MotiliCap GI Monitoring System?

MotiliCap GI Monitoring System is manufactured by Anx Robotica Corporation.

What is the FDA product code for MotiliCap GI Monitoring System?

The FDA product code for MotiliCap GI Monitoring System is NYV.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Anx Robotica Corporation

K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

Related Devices (Code: NYV)

K250940Atmo Gas Capsule SystemAtmo Biosciences, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑