meddevicedb.com FDA Device Reference

Ambu® aScope™ Gastro, Ambu® aBox™2

K212382 Class II Traditional
Decision Date
2022-02-03
Sponsor / Applicant
Ambu A/S

Technical Specification

510(k) Submission ID K212382
Product Code FDS
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1500
Decision Date 2022-02-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Ambu® aScope™ Gastro, Ambu® aBox™2 received FDA 510(k) clearance under submission number K212382, sponsored by Ambu A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2022-02-03.

Classification & Regulation

This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.