510(k) K182272 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
| Applicant | Sterilmed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 15, 2019 |
| Received | Aug 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182272
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.