The following data is part of a premarket notification filed by Nds Surgical Imaging, Llc. with the FDA for Radiance Ultra Series Zerowire Embedded.
| Device ID | K161228 |
| 510k Number | K161228 |
| Device Name: | Radiance Ultra Series ZeroWire Embedded |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NDS SURGICAL IMAGING, LLC. 5750 HELLYER AVE San Jose, CA 95138 |
| Contact | Jim Leng |
| Correspondent | Jim Leng NDS SURGICAL IMAGING, LLC. 5750 HELLYER AVE San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818089020242 | K161228 | 000 |
| 00851455007638 | K161228 | 000 |
| 00851455007645 | K161228 | 000 |
| 00818089020167 | K161228 | 000 |
| 00818089020174 | K161228 | 000 |
| 00818089020181 | K161228 | 000 |
| 00818089020198 | K161228 | 000 |
| 00818089020204 | K161228 | 000 |
| 00818089020211 | K161228 | 000 |
| 00818089020228 | K161228 | 000 |
| 00818089020235 | K161228 | 000 |
| 00851455007621 | K161228 | 000 |