Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K171336 |
Device Name |
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath |
Applicant |
Henke-Sass, Wolf GmbH |
Keltenstrasse 1 |
Tuttlingen,
DE
78532
|
|
Applicant Contact |
Anna Reifschneider |
Correspondent |
Henke-Sass, Wolf GmbH |
Keltenstrasse 1 |
Tuttlingen,
DE
78532
|
|
Correspondent Contact |
Anna Reifschneider |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/08/2017 |
Decision Date | 12/07/2017 |
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
|
|
|