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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 the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2020-08-19 under 510(k) 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. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K193563.

When did Medline ReNewal Reprocessed Harmonic ACE+7 Shears receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ReNewal Reprocessed Harmonic ACE+7 Shears?

The FDA 510(k) record lists Surgical Instrument Service and Savings Inc.(Dba Medline Ren as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Surgical Instrument Service and Savings Inc.(Dba Medline Ren 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.

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)K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerK170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorK153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerK151617Livewire Electrophysiology Catheter

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 SolutionsK190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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