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)
FDA 510(k) K250898 · Stryker Sustainability Solutions
510(k) numberK250898
Submission
- Device name
- 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)
- Applicant
- Stryker Sustainability Solutions
Tempe, AZ, US - Received
- March 25, 2025
- Decision date
- August 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments
- Device class
- Unclassified
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…
Other 510(k)s with product code NLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special | Stryker Sustainability Solutions | 07/03/2024SE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional | Stryker Sustainability Solutions | 02/20/2024SE |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional | Stryker Sustainability Solutions | 03/16/2021SE |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 08/19/2020SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | Sterilmed, Inc. | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | Sterilmed, Inc. | 04/15/2019SE |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | Surgical Instrument Service and Savings, Inc. | 07/12/2018SE |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 07/03/2017SE |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | Stryker Sustainability Solutions | 04/05/2017SE |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional | Stryker Sustainability Solutions | 02/23/2017SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | 06/18/2026SE |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional | 10/22/2024SE |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special | 07/03/2024SE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional | 02/20/2024SE |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ · Special | 07/25/2023SE |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI · Special | 03/28/2023SE |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special | 03/28/2023SE |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional | 12/04/2022SE |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI · Traditional | 05/25/2022SE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | 05/13/2022SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K250898) received a 510(k) decision of Substantially Equivalent on August 14, 2025, 142 days after the submission was received.
What is the product code of K250898?
The FDA product code is NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments, a Unclassified device.