FDA 510(k)

SB Knife Jr2 (MD-47702 and MD-47702L)

Número K: K241855 · 2025-03-26

RequerenteSb-Kawasumi Laboratories, Inc.

Data da decisão2025-03-26

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SB Knife Jr2 (MD-47702 and MD-47702L) is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K241855. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SB Knife Jr2 (MD-47702 and MD-47702L)?

SB Knife Jr2 (MD-47702 and MD-47702L) is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K241855.

When did SB Knife Jr2 (MD-47702 and MD-47702L) receive FDA 510(k) clearance?

SB Knife Jr2 (MD-47702 and MD-47702L) received FDA 510(k) clearance on 2025-03-26, under 510(k) number K241855.

Who is the listed applicant for SB Knife Jr2 (MD-47702 and MD-47702L)?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SB Knife Jr2 (MD-47702 and MD-47702L)?

The FDA product code for SB Knife Jr2 (MD-47702 and MD-47702L) is KNS.

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 Sb-Kawasumi Laboratories, Inc. como candidato(a)

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)K220799K-SHIELD Zen

Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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.