NLQ · Single-Use Reprocessed Ultrasonic Surgical Instruments
· Class U
Overview
| Product Code | NLQ |
|---|---|
| Device Name | Single-Use Reprocessed Ultrasonic Surgical Instruments |
| Device Class | Class U |
| Review Panel |
Identification
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 Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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) | Stryker Sustainability Solutions | Aug 14, 2025 | SESE |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | Stryker Sustainability Solutions | Jul 3, 2024 | SESE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | Stryker Sustainability Solutions | Feb 20, 2024 | SESE |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | Stryker Sustainability Solutions | Mar 16, 2021 | SESE |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | Aug 19, 2020 | SESE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Sterilmed, Inc. | Aug 15, 2019 | SESE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Sterilmed, Inc. | Apr 15, 2019 | SESE |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings, Inc. | Jul 12, 2018 | SESE |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | Jul 3, 2017 | SESE |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Stryker Sustainability Solutions | Apr 5, 2017 | SESE |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | Stryker Sustainability Solutions | Feb 23, 2017 | SESE |
| K151405 | Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology | Surgical Instrument Services and Savings(Dba Medline Renewal | Jan 26, 2016 | SESE |
| K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology | Surgical Instrument Services and Savings, Inc. | Dec 16, 2015 | SESE |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | Sterilmed, Inc. | May 20, 2015 | SESE |
| K132566 | REPROCESSED HARMONIC SHEAR | Sterilmed, Inc. | Jun 14, 2014 | SESE |
| K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY | Stryker Sustainability Solutions | May 1, 2014 | SESE |
| K124033 | MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS | Surgical Instruments Service and Savings, Inc. | Jan 7, 2014 | SESE |
| K111794 | REPROCESSED HARMONIC SCALPEL | Sterilmed, Inc. | Jan 11, 2012 | SESE |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | Ascent Healthcare Solutions | May 12, 2010 | SESE |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | Ascent Healthcare Solutions | Mar 4, 2010 | SESE |
Top Applicants
- Sterilmed, Inc. — 8 clearances
- Stryker Sustainability Solutions — 7 clearances
- Ascent Healthcare Solutions — 2 clearances
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren — 2 clearances
- Vanguard Medical Concepts, Inc. — 2 clearances
