Device Classification Name |
Snare, Flexible
|
510(k) Number |
K122462 |
Device Name |
ROTH NET RETRIEVER |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
CARROLL MARTIN |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
CARROLL MARTIN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/13/2012 |
Decision Date | 09/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|