Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K232880 |
Device Name |
Inzii Ripstop Redeployable Retrieval System |
Applicant |
Applied Medical Resources Corporation |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Niharika Niranjan Mirji |
Correspondent |
Applied Medical Resources Corporation |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
Niharika Niranjan Mirji |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/18/2023 |
Decision Date | 11/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|