FDA 510(k) Applications Submitted by Scivita Medical Technology Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200216 |
01/28/2020 |
4K UHD Camera System |
Scivita Medical Technology Co., Ltd. |
| K210379 |
02/09/2021 |
Broncho Videoscope System |
Scivita Medical Technology Co., Ltd. |
| K221252 |
05/02/2022 |
Scivita 4KINSIGHT ICG Imaging System |
Scivita Medical Technology Co., Ltd. |
| K231521 |
05/26/2023 |
Broncho Videoscope System |
Scivita Medical Technology Co., Ltd. |
| K222812 |
09/19/2022 |
Insufflator |
Scivita Medical Technology Co., Ltd. |
| K203255 |
11/04/2020 |
4K UHD Laparoscope |
Scivita Medical Technology Co., Ltd. |
| K243708 |
12/02/2024 |
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) |
Scivita Medical Technology Co., Ltd. |
| K240192 |
01/24/2024 |
Single-use Extraction Baskets |
Scivita Medical Technology Co., Ltd. |
| K240289 |
02/01/2024 |
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) |
Scivita Medical Technology Co., Ltd. |
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