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FDA 510(k)

McLean-Ring Enteral Feeding Tube Set

K-Number: K190084 · 2019-10-11

ApplicantCook Incorporated
Decision Date2019-10-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

McLean-Ring Enteral Feeding Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K190084. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the McLean-Ring Enteral Feeding Tube Set?

McLean-Ring Enteral Feeding Tube Set is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Cook Incorporated. The 510(k) number is K190084.

When did McLean-Ring Enteral Feeding Tube Set receive FDA 510(k) clearance?

McLean-Ring Enteral Feeding Tube Set received FDA 510(k) clearance on 2019-10-11, under 510(k) number K190084.

Who is the listed applicant for McLean-Ring Enteral Feeding Tube Set?

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

What is the FDA product code for McLean-Ring Enteral Feeding Tube Set?

The FDA product code for McLean-Ring Enteral Feeding Tube Set is KNT.

Related Clinical Trials

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Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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