Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K213597 |
Device Name |
MultiCut Solo |
Applicant |
Asclepion Laser Technologies GmbH |
Bruesseler Strasse 10 |
Jena,
DE
07747
|
|
Applicant Contact |
Tom Gruender |
Correspondent |
Asclepion Laser Technologies GmbH |
Bruesseler Strasse 10 |
Jena,
DE
07747
|
|
Correspondent Contact |
Tom Gruender |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/12/2021 |
Decision Date | 01/18/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|