FDA 510(k)

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology

Номер K: K151405 · 2016-01-26

ЗаявительSurgical Instrument Services and Savings(Dba Medline Renewal

Дата решения2016-01-26

Код продуктаNLQ

РешениеSubstantially Equivalent

Описание устройства

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Services and Savings(Dba Medline Renewal. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K151405. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology?

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Surgical Instrument Services and Savings(Dba Medline Renewal. The 510(k) number is K151405.

When did Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology received FDA 510(k) clearance on 2016-01-26, under 510(k) number K151405.

Who is the listed applicant for Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology?

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

What is the FDA product code for Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology?

The FDA product code for Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology is NLQ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NLQ)

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 Solutions K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)Stryker Sustainability Solutions K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability Solutions K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.

Официальный источник

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