510(k) K150956 ยท GCJ Laparoscope, General & Plastic Surgery
PINPOINT Endoscopic Fluorescence Imaging System
| Applicant | Novadaq Technologies, Inc., Burnaby, CA |
| Decision | Substantially Equivalent, May 23, 2016 |
| Received | Apr 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150956
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2021 | Stryker Corporation Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended u Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.