510(k) K191555 ยท LFL Instrument, Ultrasonic Surgical
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Feb 28, 2020 |
| Received | Jun 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2021 | Ethicon Endo-Surgery Inc HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Product Code: HARHD20 Open, Classified |
LFL | None listed |
| Jul 20, 2021 | Ethicon Endo-Surgery Inc HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Product Code: HARHD36 Open, Classified |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.