510(k) K161693 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
| Applicant | Stryker Sustainability Solutions, Tempe AZ, US |
| Decision | Substantially Equivalent, Feb 23, 2017 |
| Received | Jun 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2021 | Stryker Sustainability Solutions Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bl Open, Classified |
NLQ | None listed |
| May 8, 2018 | Stryker Sustainability Solutions Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36
Product Usage:
The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are i Terminated |
NLQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.