510(k) K153745 ยท NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
| Applicant | Surgical Instrument Service and Savings Inc.(Dba Medline Ren, Redmond OR, US |
| Decision | Substantially Equivalent, May 2, 2016 |
| Received | Dec 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Medline Industries, LP Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & E Open, Classified |
NUJ | None listed |
| Nov 7, 2025 | Medline Industries, LP Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & End Open, Classified |
NUJ | None listed |
| Sep 10, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR. Open, Classified |
NUJ | None listed |
| Oct 16, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument Open, Classified |
NUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.