Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider— 510(k) K182588
Substantially EquivalentSurgical Instrument Service and Savings Inc.(Dba Medline Ren
FDA 510(k) clearance K182588 for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider, Substantially Equivalent on 2018-10-31. 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
- K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
- K153745 — Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
- K151617 — Livewire Electrophysiology Catheter
Recalls naming K182588
K-number listed on FDA's recall record- Z-0475-2026 — Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Z-0476-2026 — Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Z-0477-2026 — Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Z-3093-2024 — Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
- Z-0118-2024 — MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182588.
Data sourced from openFDA. This site is unofficial and independent of the FDA.