FDA.reportPublic FDA data

510(k) K241606

Device
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
Applicant
Stryker Sustainability Solutions
510(k) number
K241606
Product code
NLQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-03
Date received
2024-06-04
Classification name
Single-Use Reprocessed Ultrasonic Surgical Instruments
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Scott English
Address
1810 W Dr.Ake Dr. Tempe AZ US 85283 85283

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NLQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250898Reprocessed 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 Solutions2025-08-14
K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability Solutions2024-02-20
K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions2021-03-16
K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren2020-08-19
K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.2019-08-15
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc.2019-04-15
K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.2018-07-12
K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren2017-07-03
K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions2017-04-05
K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions2017-02-23
K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings(Dba Medline Renewal2016-01-26
K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.2015-12-16
K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.2015-05-20
K132566REPROCESSED HARMONIC SHEARSterilmed, Inc.2014-06-14
K133672REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGYStryker Sustainability Solutions2014-05-01