Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider— 510(k) K153745
Substantially EquivalentSurgical Instrument Service and Savings Inc.(Dba Medline Ren
FDA 510(k) clearance K153745 for Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider, Substantially Equivalent on 2016-05-02. Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren
- Product code
- Code NUJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
Recent devices under product code NUJ
view all- K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
- K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer
- K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
More clearances from Surgical Instrument Service and Savings Inc.(Dba Medline Ren
view all- K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 Shears
- K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
- K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
- K151617 — Livewire Electrophysiology Catheter
Recalls naming K153745
K-number listed on FDA's recall record- Z-0468-2026 — 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 & Endoscopic, Reprocessed
- Z-0469-2026 — 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 & Endoscopic, Reprocessed
- Z-3094-2024 — 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.
- Z-0119-2024 — MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153745.
Data sourced from openFDA. This site is unofficial and independent of the FDA.