Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K152035 |
Device Name |
iSnare system-Lariat |
Applicant |
United States Endoscopy Group, Inc |
5976 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
Carroll Martin |
Correspondent |
United States Endoscopy Group, Inc |
5976 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
Carroll Martin |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/22/2015 |
Decision Date | 10/15/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|