510(k) K162885 ยท OWN Confocal Optical Imaging
SPY Phi Open Field Handheld Fluorescence Imaging System
| Applicant | Novadaq Technologies, Inc., Burnaby, CA |
| Decision | Substantially Equivalent, Jan 11, 2017 |
| Received | Oct 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162885
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2020 | Stryker Corporation Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US.
Drape/ UDI: HH2000/10858701006329;
HH9006/ 10858701006282 Open, Classified |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.