Device Classification Name |
Gastroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K232028 |
Device Name |
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) |
Applicant |
IQ Endoscopes Limited |
Basepoint Business Centre, Riverside Court Beaufort Park Way |
Chepstow,
GB
NP16 5UH
|
|
Applicant Contact |
Chris Jenkins |
Correspondent |
IQ Endoscopes Limited |
Basepoint Business Centre, Riverside Court Beaufort Park Way |
Chepstow,
GB
NP16 5UH
|
|
Correspondent Contact |
Chris Jenkins |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/07/2023 |
Decision Date | 11/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|