510(k) K193563 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
| Applicant | Surgical Instrument Service and Savings Inc.(Dba Medline Ren, Redmond OR, US |
| Decision | Substantially Equivalent, Aug 19, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R. Open, Classified |
NLQ | None listed |
| Oct 16, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument. Open, Classified |
NLQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.