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510(k) K250898

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) by Stryker Sustainability Solutions — Product Code NLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2025
Date Received
March 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single-Use Reprocessed Ultrasonic Surgical Instruments
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). 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

  • 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)
  • K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (May 13, 2022)
  • K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 (March 8, 2022)

Other clearances for product code NLQ

  • 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)
  • K202554 — Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (March 16, 2021)
  • K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 Shears (August 19, 2020)
  • K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (August 15, 2019)
  • K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (April 15, 2019)
  • K173627 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (July 12, 2018)
  • K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (July 3, 2017)
  • K170456 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (April 5, 2017)
  • K161693 — Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis (February 23, 2017)