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FDA 510(k)

Medline ReNewal Reprocessed Harmonic ACE+7 Shears

K-Number: K193563 · 2020-08-19

ApplicantSurgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision Date2020-08-19
Product CodeNLQ
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Harmonic ACE+7 Shears is a medical device manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2020-08-19 under approval number K193563. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Harmonic ACE+7 Shears?

Medline ReNewal Reprocessed Harmonic ACE+7 Shears is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K193563.

When was Medline ReNewal Reprocessed Harmonic ACE+7 Shears approved by the FDA?

Medline ReNewal Reprocessed Harmonic ACE+7 Shears received FDA 510(k) clearance on 2020-08-19, under approval number K193563.

What company makes Medline ReNewal Reprocessed Harmonic ACE+7 Shears?

Medline ReNewal Reprocessed Harmonic ACE+7 Shears is manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren.

What is the FDA product code for Medline ReNewal Reprocessed Harmonic ACE+7 Shears?

The FDA product code for Medline ReNewal Reprocessed Harmonic ACE+7 Shears is NLQ.

Related Clinical Trials

NCT06608485 A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures RECRUITING

Other Devices by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider K151617Livewire Electrophysiology Catheter K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

Related Devices (Code: NLQ)

K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings(Dba Medline Renewal K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc. K190610Reprocessed 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.

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