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FDA 510(k)

Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)

Número K: K240069 · 2024-02-08

RequerenteEndolumik
Data da decisão2024-02-08
Código do produtoKNT
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) is the device name listed in this FDA 510(k) record. The listed applicant is Endolumik. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K240069. 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 Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)?

Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Endolumik. The 510(k) number is K240069.

When did Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) receive FDA 510(k) clearance?

Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) received FDA 510(k) clearance on 2024-02-08, under 510(k) number K240069.

Who is the listed applicant for Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)?

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

What is the FDA product code for Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)?

The FDA product code for Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) is KNT.

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Dispositivos Relacionados (Código: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota 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.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ 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

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