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FDA 510(k)

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider

K-Number: K180451 · 2018-04-20

ApplicantStryker Sustainability Solutions
Decision Date2018-04-20
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider 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 2018-04-20 under 510(k) number K180451. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider?

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K180451.

When did Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider receive FDA 510(k) clearance?

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180451.

Who is the listed applicant for Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider?

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 LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider?

The FDA product code for Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider is NUJ.

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)

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Related Devices (Code: NUJ)

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.

K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLCK191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLCK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren

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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