Device Classification Name |
forceps, biopsy, electric
|
510(k) Number |
K171973 |
Device Name |
Captura® Disposable Hot Biopsy Forceps |
Applicant |
Wilson-Cook Medical, Inc. |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Ashley Howard |
Correspondent |
Wilson-Cook Medical, Inc. |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Ashley Howard |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 06/30/2017 |
Decision Date | 03/21/2018 |
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
|
|
|