510(k) K161228 ยท GCJ Laparoscope, General & Plastic Surgery
Radiance Ultra Series ZeroWire Embedded
| Applicant | Nds Surgical Imaging, LLC, San Jose CA, US |
| Decision | Substantially Equivalent, May 26, 2016 |
| Received | May 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.