Device Classification Name |
esophagoscope (flexible or rigid)
|
510(k) Number |
K203450 |
Device Name |
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) |
Applicant |
CapNostics, LLC |
9724 Colts Neck Lane |
Concord,
NC
28027
|
|
Applicant Contact |
Martin von Dyck |
Correspondent |
CapNostics, LLC |
9724 Colts Neck Lane |
Concord,
NC
28027
|
|
Correspondent Contact |
Martin von Dyck |
Regulation Number | 874.4710
|
Classification Product Code |
|
Date Received | 11/23/2020 |
Decision Date | 05/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|