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510(k) K182588

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider by Surgical Instrument Service and Savings Inc.(Dba Medline Ren — Product Code NUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2018
Date Received
September 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

  • K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer T (November 15, 2024)
  • K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 Shears (August 19, 2020)
  • K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (July 3, 2017)
  • K153745 — Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (May 2, 2016)
  • K151617 — Livewire Electrophysiology Catheter (January 22, 2016)

Other clearances for product code NUJ

  • K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (April 29, 2024)
  • K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (March 28, 2023)
  • K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (May 13, 2022)
  • K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer (April 7, 2022)
  • K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (October 22, 2019)
  • K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider (April 23, 2018)
  • K180451 — Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (April 20, 2018)
  • K173214 — NES Reprocessed RF Stylet (RFS) (March 27, 2018)
  • K173740 — Reprocessed DePuy Mitek Ablation Wand (March 19, 2018)
  • K173741 — Reprocessed ArthoCare Ablation Wand (March 5, 2018)