The following data is part of a premarket notification filed by Nds Surgical Imaging, Llc. with the FDA for Radiance Ultra 32 4k Zerowire Duo.
| Device ID | K222890 |
| 510k Number | K222890 |
| Device Name: | RADIANCE ULTRA 32 4K ZEROWIRE DUO |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NDS Surgical Imaging, LLC. 100 Paramount Drive, Suite 101 Sarasota, FL 34232 |
| Contact | Jim Leng |
| Correspondent | Jim Leng NDS Surgical Imaging, LLC. 100 Paramount Drive, Suite 101 Sarasota, FL 34232 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-23 |
| Decision Date | 2022-10-19 |