Device Classification Name |
Instrument, Biopsy
|
510(k) Number |
K222462 |
Device Name |
Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) |
Applicant |
ITP Innovative Tomography Products GmbH |
Universitaetsstr. 136 |
Bochum,
DE
44799
|
|
Applicant Contact |
Dr. Heinz-Werner Henke |
Correspondent |
ITP Innovative Tomography Products GmbH |
Universitaetsstr. 136 |
Bochum,
DE
44799
|
|
Correspondent Contact |
Dominik Fraemke |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 08/15/2022 |
Decision Date | 01/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|