The following data is part of a premarket notification filed by Scivita Medical Technology Co., Ltd. with the FDA for 4k Uhd Laparoscope.
| Device ID | K203255 |
| 510k Number | K203255 |
| Device Name: | 4K UHD Laparoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Scivita Medical Technology Co., Ltd. No. 8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu Prov., China Suzhou, CN 215000 |
| Contact | Ruqin Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | GCJ |
| Subsequent Product Code | HET |
| Subsequent Product Code | NMH |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971381250272 | K203255 | 000 |
| 06971381250176 | K203255 | 000 |
| 16971381250180 | K203255 | 000 |
| 16971381250197 | K203255 | 000 |
| 16971381250203 | K203255 | 000 |
| 16971381250210 | K203255 | 000 |
| 16971381250227 | K203255 | 000 |
| 16971381250234 | K203255 | 000 |
| 16971381250241 | K203255 | 000 |
| 16971381250258 | K203255 | 000 |
| 16971381250265 | K203255 | 000 |
| 16971381250166 | K203255 | 000 |