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510(k) K233471

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) by Stryker Sustainability Solutions — Product Code NLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2024
Date Received
October 25, 2023
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

  • 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)
  • 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)
  • K211140 — Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo (March 8, 2022)

Other clearances for product code NLQ

  • K250898 — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter S (August 14, 2025)
  • K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocess (July 3, 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)