FDA 510(k)

KARL STORZ ICG Imaging System

Número K: K202925 · 2020-12-17

RequerenteKarl Storz Endoscopy_America, Inc.

Data da decisão2020-12-17

Código do produtoOWN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

KARL STORZ ICG Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy_America, Inc.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K202925. 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 ICG Imaging System?

KARL STORZ ICG Imaging System is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Karl Storz Endoscopy_America, Inc.. The 510(k) number is K202925.

When did KARL STORZ ICG Imaging System receive FDA 510(k) clearance?

KARL STORZ ICG Imaging System received FDA 510(k) clearance on 2020-12-17, under 510(k) number K202925.

Who is the listed applicant for KARL STORZ ICG Imaging System?

The FDA 510(k) record lists Karl Storz Endoscopy_America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ ICG Imaging System?

The FDA product code for KARL STORZ ICG Imaging System 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

Outros registros que listam Karl Storz Endoscopy_America, Inc. como candidato(a)

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

Ver todos os 46 dispositivos →

Dispositivos Relacionados (Código: OWN)

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG 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.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.