FDA 510(k)

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Número K: K222643 · 2022-10-19

Data da decisão2022-10-19

Código do produtoPBY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is the device name listed in this FDA 510(k) record. The listed applicant is Sirius Medical Systems B.V.. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K222643. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Sirius Medical Systems B.V.. The 510(k) number is K222643.

When did Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit receive FDA 510(k) clearance?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit received FDA 510(k) clearance on 2022-10-19, under 510(k) number K222643.

Who is the listed applicant for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

The FDA 510(k) record lists Sirius Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

The FDA product code for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is PBY.

Ensaios clínicos relacionados

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.

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

Outros registros que listam Sirius Medical Systems B.V. como candidato(a)

K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Dispositivos Relacionados (Código: PBY)

K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)Health Beacons, Inc.K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.