510(k) K170456 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
| Applicant | Stryker Sustainability Solutions, Tempe AZ, US |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Feb 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2025 | Stryker Sustainability Solutions HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length
REF: HAR9F,
Reprocessed Device for Single Use, STERILEEO, RX ONLY Open, Classified |
NLQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.