FDA 510(k)

LOOK PTFE Suture

Номер K: K160744 · 2016-07-13

ЗаявительSurgical Specialties Corporation

Дата решения2016-07-13

Код продуктаNBY

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

LOOK PTFE Suture is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corporation. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K160744. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the LOOK PTFE Suture?

LOOK PTFE Suture is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Surgical Specialties Corporation. The 510(k) number is K160744.

When did LOOK PTFE Suture receive FDA 510(k) clearance?

LOOK PTFE Suture received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160744.

Who is the listed applicant for LOOK PTFE Suture?

The FDA 510(k) record lists Surgical Specialties Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOOK PTFE Suture?

The FDA product code for LOOK PTFE Suture is NBY.

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: NBY)

K231277TissueStatDurastat, LLC K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures K180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami Surgical K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

Официальный источник

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