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FDA 510(k)

ENTUBE TM, ENTERAL FEEDING TUBE

K-Number: K861427 · 1986-07-18

ApplicantEntech, Inc.
Decision Date1986-07-18
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTUBE TM, ENTERAL FEEDING TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Entech, Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K861427. 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 ENTUBE TM, ENTERAL FEEDING TUBE?

ENTUBE TM, ENTERAL FEEDING TUBE is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Entech, Inc.. The 510(k) number is K861427.

When did ENTUBE TM, ENTERAL FEEDING TUBE receive FDA 510(k) clearance?

ENTUBE TM, ENTERAL FEEDING TUBE received FDA 510(k) clearance on 1986-07-18, under 510(k) number K861427.

Who is the listed applicant for ENTUBE TM, ENTERAL FEEDING TUBE?

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

What is the FDA product code for ENTUBE TM, ENTERAL FEEDING TUBE?

The FDA product code for ENTUBE TM, ENTERAL FEEDING TUBE is KNT.

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Other records listing Entech, Inc. as applicant

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.

K891371GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFGK890430ENTAINER(TM) ENTERAL FEEDING CONTAINERK873343ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEMK873444ENTECH ENTERAL PUMP AND SETK871019ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SETK861552TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS

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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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