Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K223856 |
Device Name |
NuEra Tight RF Family |
Applicant |
BIOS s.r.l. |
Via Guido Rossa 10/12 |
Vimodrone,
IT
20055
|
|
Applicant Contact |
Manuela Brambilla |
Correspondent |
BIOS s.r.l. |
Via Guido Rossa 10/12 |
Vimodrone,
IT
20055
|
|
Correspondent Contact |
Manuela Brambilla |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2022 |
Decision Date | 08/11/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04406935
|
Reviewed by Third Party |
No
|
Combination Product |
No
|