NLQ — Single-Use Reprocessed Ultrasonic Surgical Instruments Class U
Classification Details
- Product Code
- NLQ
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250898 | stryker sustainability solutions | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter S | August 14, 2025 |
| K241606 | stryker sustainability solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocess | July 3, 2024 |
| K233471 | stryker sustainability solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocess | February 20, 2024 |
| K202554 | stryker sustainability solutions | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | March 16, 2021 |
| K193563 | surgical instrument service and savings inc.(dba medline ren | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | August 19, 2020 |
| K190610 | sterilmed | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | August 15, 2019 |
| K182272 | sterilmed | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | April 15, 2019 |
| K173627 | surgical instrument service and savings | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | July 12, 2018 |
| K170955 | surgical instrument service and savings inc.(dba medline ren | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | July 3, 2017 |
| K170456 | stryker sustainability solutions | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | April 5, 2017 |
| K161693 | stryker sustainability solutions | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | February 23, 2017 |
| K151405 | surgical instrument services and savings(dba medline renewal | Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Techno | January 26, 2016 |
| K150524 | surgical instrument services and savings | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Techn | December 16, 2015 |
| K143562 | sterilmed | Reprocessed Cordless Ultrasonic Dissection Device | May 20, 2015 |
| K132566 | sterilmed | REPROCESSED HARMONIC SHEAR | June 14, 2014 |
| K133672 | stryker sustainability solutions | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY | May 1, 2014 |
| K124033 | surgical instruments service and savings | MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS | January 7, 2014 |
| K111794 | sterilmed | REPROCESSED HARMONIC SCALPEL | January 11, 2012 |
| K100537 | ascent healthcare solutions | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FC | May 12, 2010 |
| K093702 | ascent healthcare solutions | REPROCESSED ULTRASONIC COAGULATING SHEARS | March 4, 2010 |