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FDA 510(k)

Reprocessed LigaSure Maryland Jaw Sealer/Divider

Número K: K180499 · 2018-04-23

RequerenteStryker Sustainability Solutions
Data da decisão2018-04-23
Código do produtoNUJ
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed LigaSure Maryland Jaw 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 2018-04-23 under 510(k) number K180499. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed LigaSure Maryland Jaw Sealer/Divider?

Reprocessed LigaSure Maryland Jaw Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K180499.

When did Reprocessed LigaSure Maryland Jaw Sealer/Divider receive FDA 510(k) clearance?

Reprocessed LigaSure Maryland Jaw Sealer/Divider received FDA 510(k) clearance on 2018-04-23, under 510(k) number K180499.

Who is the listed applicant for Reprocessed LigaSure Maryland Jaw 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 Maryland Jaw Sealer/Divider?

The FDA product code for Reprocessed LigaSure Maryland Jaw Sealer/Divider is NUJ.

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Outros registros que listam Stryker Sustainability Solutions como candidato(a)

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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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Dispositivos Relacionados (Código: NUJ)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Fonte oficial

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