FDA 510(k)

KARL STORZ TIPCAM1 Rubina

Número K: K262547 · 2026-09-21

Data da decisão2026-09-21

Código do produtoOWN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

KARL STORZ TIPCAM1 Rubina is the device name listed in this FDA 510(k) record. The listed applicant is KALR STORZ SE & Co. KG. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K262547. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KARL STORZ TIPCAM1 Rubina?

KARL STORZ TIPCAM1 Rubina is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is KALR STORZ SE & Co. KG. The 510(k) number is K262547.

When did KARL STORZ TIPCAM1 Rubina receive FDA 510(k) clearance?

KARL STORZ TIPCAM1 Rubina received FDA 510(k) clearance on 2026-09-21, under 510(k) number K262547.

Quem é o solicitante listado para o KARL STORZ TIPCAM1 Rubina?

The FDA 510(k) record lists KALR STORZ SE & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ TIPCAM1 Rubina?

The FDA product code for KARL STORZ TIPCAM1 Rubina is OWN.

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

Dispositivos Relacionados (Código: OWN)

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker Endoscopy K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

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.