Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K214046 |
Device Name |
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable |
Applicant |
Stryker |
5900 Optical Court |
San Jose,
CA
95138
|
|
Applicant Contact |
Michelle Hughes |
Correspondent |
Stryker |
5900 Optical Court |
San Jose,
CA
95138
|
|
Correspondent Contact |
Michelle Hughes |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/27/2021 |
Decision Date | 05/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|