Device Classification Name |
Duodenoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K161222 |
Device Name |
PENTAX MEDICAL ED-3490TK, Video Duodenoscope |
Applicant |
PENTAX MEDICAL |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Applicant Contact |
KANCHANA IYER |
Correspondent |
PENTAX MEDICAL |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Correspondent Contact |
William Goeller |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/29/2016 |
Decision Date | 02/07/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|