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FDA 510(k)

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis

N.º K: K202554 · 2021-03-16

SolicitanteStryker Sustainability Solutions
Fecha de decisión2021-03-16
Código de productoNLQ
DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2021-03-16 under 510(k) number K202554. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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 2021-03-16. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K202554.

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 2021-03-16, under 510(k) number K202554.

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Stryker Sustainability Solutions como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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)

Ver todos los 25 dispositivos →

Dispositivos relacionados (Código: NLQ)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 SolutionsK193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline RenK190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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