FDA 510(k)

Bowel Management Device, Bowel Management Irrigation Set

Número K: K180026 · 2018-06-01

RequerenteApplied Medical Technology, Inc.

Data da decisão2018-06-01

Código do produtoKNT

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Bowel Management Device, Bowel Management Irrigation Set is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180026. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Bowel Management Device, Bowel Management Irrigation Set?

Bowel Management Device, Bowel Management Irrigation Set is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K180026.

When did Bowel Management Device, Bowel Management Irrigation Set receive FDA 510(k) clearance?

Bowel Management Device, Bowel Management Irrigation Set received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180026.

Who is the listed applicant for Bowel Management Device, Bowel Management Irrigation Set?

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

What is the FDA product code for Bowel Management Device, Bowel Management Irrigation Set?

The FDA product code for Bowel Management Device, Bowel Management Irrigation Set 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 Applied Medical Technology, Inc. como candidato(a)

K252438Explant Express K240514AMT Low-Profile Suprapubic Catheter & Drainage Set K241111AMT Suture Passer K222846AMT G-Tube Balloon Gastrostomy Feeding Device K202539Nutriglide(TM) Nasal Feeding Tube K193612AMT Suture Delivery System

Ver todos os 11 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.