FDA 510(k)

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

Número K: K230752 · 2023-09-15

RequerenteFUJIFILM Healthcare Americas Corporation

Data da decisão2023-09-15

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K230752. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K230752.

When did Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) receive FDA 510(k) clearance?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) received FDA 510(k) clearance on 2023-09-15, under 510(k) number K230752.

Who is the listed applicant for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

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

What is the FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

The FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is FED.

Outros registros que listam FUJIFILM Healthcare Americas Corporation como candidato(a)

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.

K261713Synapse PACS (7.6.0)K251204FUJIFILM Stiffening Wire Device (SW-2000)K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214C K233629APERTO Lucent MRI System K233687ECHELON Synergy V10.0

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., 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.