FDA 510(k)

Avanos* CORTRAK* 2 Enteral Access System (EAS)

Número K: K220588 · 2022-04-22

Data da decisão2022-04-22

Código do produtoKNT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Avanos* CORTRAK* 2 Enteral Access System (EAS) is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K220588. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Avanos* CORTRAK* 2 Enteral Access System (EAS)?

Avanos* CORTRAK* 2 Enteral Access System (EAS) is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K220588.

When did Avanos* CORTRAK* 2 Enteral Access System (EAS) receive FDA 510(k) clearance?

Avanos* CORTRAK* 2 Enteral Access System (EAS) received FDA 510(k) clearance on 2022-04-22, under 510(k) number K220588.

Who is the listed applicant for Avanos* CORTRAK* 2 Enteral Access System (EAS)?

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

What is the FDA product code for Avanos* CORTRAK* 2 Enteral Access System (EAS)?

The FDA product code for Avanos* CORTRAK* 2 Enteral Access System (EAS) is KNT.

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 Avanos Medical, Inc. como candidato(a)

K243572Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La K241185CORGRIP* SR NG/NI Tube Retention System K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)K240965CORTRAK* 2 Enteral Access System (20-0950)K203066COOLIEF Cooled Radiofrequency Kit Advanced K192491Coolief Radiofrequency Generator (CRG) System

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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.