Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K240174 |
Device Name |
1688 4K Camera System with Advanced Imaging Modality |
Applicant |
Stryker Endoscopy |
5900 Optical Court |
San Jose,
CA
95138
|
|
Applicant Contact |
Marlene Fraga |
Correspondent |
Stryker Endoscopy |
5900 Optical Court |
San Jose,
CA
95138
|
|
Correspondent Contact |
Marlene Fraga |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/23/2024 |
Decision Date | 02/22/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|