Single-Use Reprocessed Ultrasonic Surgical Instruments
The Single-Use Reprocessed Ultrasonic Surgical Instruments are reprocessed versions of single-use ultrasonic surgical devices used either for fragmentation, emulsification, and aspiration of soft and hard tissue or for vessel ligation during surgical procedures; reprocessing validation data must be included in the submission. These devices are unclassified (device class "U") with an unclassified reason code of 1, subject to FDA's 510(k) pathway, under product code NLQ in the General and Plastic Surgery review panel (no regulation number assigned). The devices carry no implant or life-sustaining flags.
Basic Information
- Product Code
- NLQ
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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).
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | Jul 03, 2024 | Substantially Equivalent | Stryker Sustainability Solutions |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | Feb 20, 2024 | Substantially Equivalent | Stryker Sustainability Solutions |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | Mar 16, 2021 | Substantially Equivalent | Stryker Sustainability Solutions |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Aug 19, 2020 | Substantially Equivalent | Surgical Instrument Service and Savings Inc (dba Medline ReN |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Aug 15, 2019 | Substantially Equivalent | Sterilmed, Inc. |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Apr 15, 2019 | Substantially Equivalent | Sterilmed, Inc. |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Jul 12, 2018 | Substantially Equivalent | Surgical Instrument Service and Savings Inc |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Jul 03, 2017 | Substantially Equivalent | Surgical Instrument Service and Savings Inc (dba Medline ReN |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Apr 05, 2017 | Substantially Equivalent | Stryker Sustainability Solutions |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | Feb 23, 2017 | Substantially Equivalent | STRYKER SUSTAINABILITY SOLUTIONS |
| K151405 | Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology | Jan 26, 2016 | Substantially Equivalent | Surgical Instrument Services and Savings(dba Medline ReNewal |
| K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology | Dec 16, 2015 | Substantially Equivalent | Surgical Instrument Services and Savings, Inc |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | May 20, 2015 | Substantially Equivalent | STERILMED, INC. |
| K132566 | REPROCESSED HARMONIC SHEAR | Jun 14, 2014 | Substantially Equivalent | STERILMED, INC. |
| K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY | May 01, 2014 | Substantially Equivalent | STRYKER SUSTAINABILITY SOLUTIONS |
| K124033 | MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS | Jan 07, 2014 | Substantially Equivalent | SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
| K111794 | REPROCESSED HARMONIC SCALPEL | Jan 11, 2012 | Substantially Equivalent | STERILMED, INC. |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | May 12, 2010 | Substantially Equivalent | ASCENT HEALTHCARE SOLUTIONS |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | Mar 04, 2010 | Substantially Equivalent | ASCENT HEALTHCARE SOLUTIONS |
| K083060 | REPROCESSED HARMONIC SCALPEL | Jan 09, 2009 | Substantially Equivalent | STERILMED, INC. |
| K043358 | REPROCESSED ULTRASONIC SCALPELS | Jun 06, 2005 | Substantially Equivalent | ALLIANCE MEDICAL CORP. |
| K050343 | REPROCESSED HARMONIC SCALPELS | Apr 12, 2005 | Substantially Equivalent | STERILMED, INC. |
| K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | Mar 22, 2005 | Substantially Equivalent | VANGUARD MEDICAL CONCEPTS, INC. |
| K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | Mar 22, 2005 | Substantially Equivalent | VANGUARD MEDICAL CONCEPTS, INC. |
| K030598 | MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS | Jan 23, 2004 | Substantially Equivalent | MEDISISS |
| K012571 | REPROCESSED HARMONIC | Nov 07, 2001 | Substantially Equivalent | STERILMED, INC. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.