Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K192103 |
Device Name |
Thunderbeat Open Fine Jaw Type X Hand Instrument |
Applicant |
Olympus Medical Systems Corp. |
2951 Ishikawa-cho |
Hachioji-Shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Gyrus ACMI inc. |
136 Turnpike Road |
Southborough,
MA
01772
|
|
Correspondent Contact |
Christina Flores |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/05/2019 |
Decision Date | 05/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|