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FDA 510(k)

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

Número K: K190610 · 2019-08-15

RequerenteSterilmed, Inc.
Data da decisão2019-08-15
Código do produtoNLQ
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K190610. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Sterilmed, Inc.. The 510(k) number is K190610.

When did Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology receive FDA 510(k) clearance?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology received FDA 510(k) clearance on 2019-08-15, under 510(k) number K190610.

Who is the listed applicant for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

The FDA product code for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is NLQ.

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K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)K240826Cáteter de Electrofisiologia DECANAV™ Reprocessado; Cáteter de Electrofisiologia WEBSTER® Duo-Decapolar ReprocessadoK190478Reprocessed ViewFlex™ Xtra ICE CatheterK182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisK161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersK161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

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Dispositivos Relacionados (Código: NLQ)

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.

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 SolutionsK193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline RenK182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc.

Fonte oficial

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