510(k) K212614 ยท LFL Instrument, Ultrasonic Surgical
Ultrasonic Scalpel System
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., Cixi, CN |
| Decision | Substantially Equivalent, Jul 18, 2022 |
| Received | Aug 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212614
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.