Decision Date2017-02-23
Product CodeNLQ
DecisionSubstantially Equivalent
Device Summary
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K161693. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis?
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K161693.
When did Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis receive FDA 510(k) clearance?
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161693.
Who is the listed applicant for Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis?
The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis?
The FDA product code for Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis is NLQ.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Stryker Sustainability Solutions as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingK250898Reprocessed 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)K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031) View all 25 devices →
Related Devices (Code: NLQ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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 SolutionsK241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)Stryker Sustainability SolutionsK233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability SolutionsK202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability SolutionsK193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline RenK190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.