FDA 510(k)

OviTex PRS (Long Term Resorbable)

Номер K: K214070 · 2023-03-21

ЗаявительTela Bio

Дата решения2023-03-21

Код продуктаFTM

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

OviTex PRS (Long Term Resorbable) is the device name listed in this FDA 510(k) record. The listed applicant is Tela Bio. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K214070. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the OviTex PRS (Long Term Resorbable)?

OviTex PRS (Long Term Resorbable) is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Tela Bio. The 510(k) number is K214070.

When did OviTex PRS (Long Term Resorbable) receive FDA 510(k) clearance?

OviTex PRS (Long Term Resorbable) received FDA 510(k) clearance on 2023-03-21, under 510(k) number K214070.

Who is the listed applicant for OviTex PRS (Long Term Resorbable)?

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

What is the FDA product code for OviTex PRS (Long Term Resorbable)?

The FDA product code for OviTex PRS (Long Term Resorbable) is FTM.

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: FTM)

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific K250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.