510(k) K150549 ยท GCJ Laparoscope, General & Plastic Surgery
Reactor(TM) Trocar and Sleeve
| Applicant | Sharp Medical Prducts, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jun 1, 2015 |
| Received | Mar 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2021 | Sharp Medical Products SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.