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510(k) K180451

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider by Stryker Sustainability Solutions — Product Code NUJ

K180451 is an FDA 510(k) premarket notification submitted by Stryker Sustainability Solutions for the device "Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider". The FDA issued a decision of Substantially Equivalent on April 20, 2018. The device falls under product code NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed), a Class II device regulated under 21 CFR 878.4400. Stryker Sustainability Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2018
Date Received
February 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 Stryker Sustainability Solutions

  • K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (June 18, 2026)
  • K250898 — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter S (August 14, 2025)
  • K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul (October 22, 2024)
  • K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocess (July 3, 2024)
  • K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocess (February 20, 2024)
  • K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031) (July 25, 2023)
  • K230255 — Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 (March 28, 2023)
  • K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (March 28, 2023)
  • K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls (December 4, 2022)
  • K220481 — Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) (May 25, 2022)

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)
  • K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (October 31, 2018)
  • K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider (April 23, 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)

FDA data resources