Device Classification Name |
forceps, biopsy, electric
|
510(k) Number |
K171916 |
Device Name |
Single Use Hot Biopsy Forceps FD-231 |
Applicant |
Olympus Medical Systems Corp. |
2951 Ishikawa-cho |
Hachioji-shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Olympus Corporation of the Americas |
3500 Corporate Parkway PO Box 610 |
Center Valley,
PA
18034 -0610
|
|
Correspondent Contact |
Sheri L. Musgnung |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 06/26/2017 |
Decision Date | 10/13/2017 |
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
|
|
|